LIC · Class II · 21 CFR 866.3390

FDA Product Code LIC: Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae

Leading manufacturers include New Horizons Diagnostics Co., Pharmacia, Inc. and Meridian Diagnostics, Inc..

9
Total
9
Cleared
83d
Avg days
1982
Since

FDA 510(k) Cleared Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae Devices (Product Code LIC)

9 devices
1–9 of 9
Cleared May 22, 1992
PHADEBACT MONOCLONAL GC TEST, MODIFICATION
K921075
Karo Bio Diagnostics AB
Microbiology · 84d
Cleared Aug 07, 1991
IDEIA(TM) CHLAMYDIA, MODIFICATION
K911430
Novo Nordisk Diagnostics, Ltd.
Microbiology · 132d
Cleared Jul 01, 1988
G-MARK
K880076
Bainbridge Laboratories, Inc.
Microbiology · 172d
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078
Meridian Diagnostics, Inc.
Microbiology · 64d
Cleared May 13, 1987
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
K871105
New Horizons Diagnostics Co.
Microbiology · 55d
Cleared Jul 12, 1985
PHADEBACT MONOCLONAL GC OMNI TEST
K851650
Pharmacia, Inc.
Toxicology · 81d
Cleared Mar 13, 1985
PHADEBACT MONOCLONAL GC TEST
K850351
Pharmacia, Inc.
Microbiology · 44d
Cleared Aug 04, 1982
IMPROVED GONO GEN
K821362
New Horizons Diagnostics Co.
Microbiology · 89d
Cleared Jan 29, 1982
NEISSERIA GONORRHOEAE TEST
K820007
New Horizons Diagnostics Co.
Microbiology · 25d

About Product Code LIC - Regulatory Context