LIC · Class II · 21 CFR 866.3390

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

Leading manufacturers include 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 Dec 09, 1987
MERITEC(TM)-GC
K874078
Meridian Diagnostics, Inc.
Microbiology · 64d
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

About Product Code LIC - Regulatory Context