LIC
9 FDA 510(k) clearances · Product code
81 daysmedian time to decision
172 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PHADEBACT MONOCLONAL GC TEST, MODIFICATION (K921075) | Karo Bio Diagnostics AB | 1992-05-22 |
| IDEIA(TM) CHLAMYDIA, MODIFICATION (K911430) | Novo Nordisk Diagnostics, Ltd. | 1991-08-07 |
| G-MARK (K880076) | Bainbridge Laboratories, Inc. | 1988-07-01 |
| MERITEC(TM)-GC (K874078) | Meridian Diagnostics, Inc. | 1987-12-09 |
| THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (K871105) | New Horizons Diagnostics Co. | 1987-05-13 |
| PHADEBACT MONOCLONAL GC OMNI TEST (K851650) | Pharmacia, Inc. | 1985-07-12 |
| PHADEBACT MONOCLONAL GC TEST (K850351) | Pharmacia, Inc. | 1985-03-13 |
| IMPROVED GONO GEN (K821362) | New Horizons Diagnostics Co. | 1982-08-04 |
| NEISSERIA GONORRHOEAE TEST (K820007) | New Horizons Diagnostics Co. | 1982-01-29 |
Track LIC automatically
Every clearance here is in the API, with alerts when new ones post.