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U.S. Department of Health & Human Services Records processed under FOIA Request 2014-5115; Released 10/15/14 U.S. Department of Health & Human Services Food and Drug Administration SAVE REQUEST USER: (ldt) FOLDER: K933121 - 50 pages COMPANY: BIOCLINICAL SYSTEMS, INC. (BIOCSYST) PRODUCT: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (JTY) SUMMARY: Product: MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR DATE REQUESTED: Oct 8, 2014 DATE PRINTED: Oct 8, 2014 Note: Printed 5600 Fishers Lane, HFI-35, Room 6-30, Rockville, MD 20857 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 510(x) ROUTE SLIP 510(k) NUMBER K933121 PANEL MI DIVISION DCLD BRANCH TRADE NAME MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR COMMON NAME PRODUCT CODE APPLICANT BIOCLINICAL SYSTEMS, INC. SHORT NAME BIOCSYST CONTACT KATHRYN POWERS DIVISION ADDRESS 9040 JUNCTION DR. SUITE ONE ANNAPOLIS JUNCTION, MD 20701 PHONE N0. (301) 498-9550 FAX NO. (301) 470-4129 MANUFACTURER BIOCLINICAL SYSTEMS, INC. REGISTRATION NO. 1120183 DATE ON SUBMISSION 25-JUN-93 DATE DUE TO 510(x) STAFF DATE RECEIVED IN ODE 2 - 3 DATE DECISION DUE 23-SEP-93 DECISION DECISION DATE d 1 ý. U PPLEMENTS SUBMITTED RECEIVED DUE POS DUE OUT SUPP001 24-AUG-93 25-AUG-93 08-NOV-93 23-NOV-93 OUT GOING CORRESPONDENCE SUPP001 18-AUG-93 17-SEP-93 ') C n r rr n I 1115---ý r-P ;. FEB- 7 1994 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 SEAp(, OtA'H (1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ýK oNbYdla Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Phil Buckner HealthLink 3611 St. Johns Bluff Road South Suite 1 Jacksonville, FL 32224 Re-'31124 Microbiological Culture Media, Chocolate Agar K933122 Microbiological Culture Media, Martin Lewis Agar K945911 Culture Media, Antimicrobial Susceptibility Test K950196 Culture Media, for Isolation of Pathogenic Neisseria Dear Mr. Nickel: We have reviewed your letters, dated August 25, 1998, stating that the rights to the above referenced premarket notifications (510(k)s) have been transferred. Transfer of 510(k) rights alone does not require submission of a new 510(k) under 21 CFR 807.81(a)(3). Consequently, we can not change the name of the original 510(K) submitter in our database. We suggest that information showing the transfer of the 510(k) and their current ownership should be maintained in your files for review by an FDA investigator. You may contact the Center for Devices and Radiological Health's Office of Compliance at (301) 594-4692 if you have any questions on what information we expect to be maintained in your files. Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 Page 2 - Mr. Buckner If you have any other questions regarding this letter, please contact the 510(k) staff at (301) 594-1190. Sincerely yours, Heather S. Rosecrans Chief, Premarket Notification Section Program Operations Staff Office of Device Evaluation Center for Devices and Radiological Health Cc: BioClinical Systems 9040 Junction Drive Suite 1 Annapolis Junction, MD 20701 9 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food And Drug Administration Memorandum Date: 41JAff From: Document Mail Center (IiFZ-401) Subject: Premarket Notification Number(s): To: Division Director: -- The attached information has been received by the 510(k) Document Mail Center (DMC), on the above referenced 510(k) submission(s). Since a final decision has been rendered, this record is officially closed. Please review the attached document and return it to the DMC, with one of the statements checked below. Feel free to note any additional comments below. Thank you for your cooperation. Information does not change status of the 510(k); no other action required by the DMC; please add to the image file. [THE DIVISION SHOULD PREPARE A CONFIRMATION LETTER - AN EXAMPLE IS AVAILABLE ON THE LAN (K25). THIS DOES NOT APPLY TO TRANSFER OF OWNERSHIP. PLEASE BRING ANY TRANSFER OF OWNERSHIP TO POS.] Additional information requires a new 510(k) however the information submitted is incomplete. Notify the company to submit a new 510(k). [THE DIVISION SHOULD PREPARE THE (K30) LETTER ON THE LAN. Additional information requires a new 510(k)please process. [THIS- WILL BE MADE INTO A NEW 510(k)]. -INFORMATION No response necessary (e.g., hard copy of fax for the truthful and accuracy statement or 510(k) statement). This information should be returned to the DMC within 10 working days from the date of this memorandum. Reviewed by: Date: Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 Ifl, 3611 St. Johns Bluif Rc>ad outh Suite 1 ealthUn Jack,onville, Florida 32224 A Family of Medical Products ['hone: (904) 996-7758 Fax: (904) 996-7078 Tuesday August 25, 1998 Office of Device Evaluation Division of Clinical Laboratory Devices -14FZ-440 Food & Drug Administration 2098 Gaither Rd. Rockville, MD 20850 Dear Sirs: Please allow this letter to serve as notice that the following 510 (k) number has been purchased. 510 (k) number Device description K933121 Microbiological culture media, Chocolate Agar - This 510 (k) originally submitted by BioClinical Systems is now owned by HealthLink 3611 St. Johns Bluff Road South, Suite 1, Jacksonville, FL 32224, Phone (904) 996-7758, Fax (904) 996-7078. Thank you for your assistance in these matters. Please feel free to call me at (90'996-7758 if you have any further questions. Sincerely, Phil Buckner HealthLink Jd Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 f,ýSItVICft.L1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration FEB 3 1994 1390 Piccard Drive Rockville,MD 20850 Ms. Kathryn Babka Powers Re: K933121/S1 Regulatory Affairs Product: Microbiological Culture Media, BIOCLINICAL SYSTEMS, INC. Chocolate Agar "For growth and isolation of 9040 Junction Drive microorganisms only" Suite One Dated: August 24, 1993 Annapolis Junction, MD 20701 Received: August 25, 1993 Regulatory Class: II Dear Ms. Powers: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations. This letter immediately will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 44.3-6597. Sincerely yours, Steven I. Cutman, M.D., M.B.A. Acting Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 DO NOT REMOVE THIS ROUTE SLIP!!!! K-93-3121 7/8/93 FROM: LETTER DATE LOGIN DATE DUE DATE BIOCLINICAL SYSTEMS, INC. I 06/25/93 I 06/25/93 I 09/23/93 ATTN: KATHRYN POWERS JUNCTION DR. (TYPE------------------------I----------9040 OF DOCUMENT: (CONTROL # SUITE ONE I 510(k) I K933121 ------------------------ ANNAPOLIS JUNCTION, MD 20701 I PHONE N0: 301-498-9550 I eHORT NAME: BIOCSYST ESTABLISHMENT NO: 1120183 _________-_____________________ _ __I ____________________-ýCONT.____CONT. :CONE ý ODE/DMC STATUS : R (REV PANEL : MI IPA-/PROD CODE(-): I g I_S ? MI/--____/-_____/____I__________ SUBJECT: MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR __________________________ ______ ______________________ __I DECISION: I-RQST INFO DATE: / / (INFO DUE DATE: / / DECISION DATE: DATE: / DATE: DATE: / / I DATE: / / I I DATE: / / DATE: / / DATE: / / I DATE: / / I I DATE: / / I DATE: / / I___ _ ___________ý_ __ __________________________________________I I Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 ''u511c Health Service Records processed under FOIA Request 2014-5115; Released 10/15/14 Memorandum Cýr_ 17 Date 1n-"or`t I - REVIEWER(S) NAME(S) AM - C*'t-ýr Subject 510(k) NOTIFICATION 11 -- -K r To THE RECORD ` It is my recommendation that the subject 510(k) Notification: V"' (A) Is substantially equivalent to marketed devices.
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