LICClass II
Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
Microbiology · 21 CFR 866.3390
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances9All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
9 clearances for this product code
- Karo Bio Diagnostics ABMay 22, 1992
K921075 · PHADEBACT MONOCLONAL GC TEST, MODIFICATION
- Novo Nordisk Diagnostics, Ltd.Aug 7, 1991
K911430 · IDEIA(TM) CHLAMYDIA, MODIFICATION
- Bainbridge Laboratories, Inc.Jul 1, 1988
K880076 · G-MARK
- Meridian Diagnostics, Inc.Dec 9, 1987
K874078 · MERITEC(TM)-GC
- New Horizons Diagnostics Co.May 13, 1987
K871105 · THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
- Pharmacia, Inc.Jul 12, 1985
K851650 · PHADEBACT MONOCLONAL GC OMNI TEST
- Pharmacia, Inc.Mar 13, 1985
K850351 · PHADEBACT MONOCLONAL GC TEST
- New Horizons Diagnostics Co.Aug 4, 1982
K821362 · IMPROVED GONO GEN