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.