Panels › Microbiology › Product code LIC · Class 2
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Regulation 866.3390
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LIC
| Company | 510(k)s | Recalls |
|---|---|---|
| New Horizons Diagnostics Co. | 3 | 0 |
| Pharmacia, Inc. | 2 | 0 |
| Bainbridge Laboratories, Inc. | 1 | 0 |
| Karo Bio Diagnostics AB | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Novo Nordisk Diagnostics, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 1992 | K921075 | PHADEBACT MONOCLONAL GC TEST, MODIFICATION Karo Bio Diagnostics AB, SC | LIC |
| Aug 7, 1991 | K911430 | IDEIA(TM) CHLAMYDIA, MODIFICATION Novo Nordisk Diagnostics, Ltd., GB | LIC |
| Jul 1, 1988 | K880076 | G-MARK Bainbridge Laboratories, Inc. | LIC |
| Dec 9, 1987 | K874078 | MERITEC(TM)-GC Meridian Diagnostics, Inc. | LIC |
| May 13, 1987 | K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE New Horizons Diagnostics Co. | LIC |
| Jul 12, 1985 | K851650 | PHADEBACT MONOCLONAL GC OMNI TEST Pharmacia, Inc. | LIC |
| Mar 13, 1985 | K850351 | PHADEBACT MONOCLONAL GC TEST Pharmacia, Inc. | LIC |
| Aug 4, 1982 | K821362 | IMPROVED GONO GEN New Horizons Diagnostics Co. | LIC |
| Jan 29, 1982 | K820007 | NEISSERIA GONORRHOEAE TEST New Horizons Diagnostics Co. | LIC |
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