GNS
9 FDA 510(k) clearances · Product code
11 daysmedian time to decision
17 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antisera, Hai, Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GOAT ANTIINFLUENZA ANTISERA AUSSR (K780696) | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| GOAT ANTI-INFLUENZA ANTISERA ATEXAS (K780697) | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| INFLUENZA HI PRESERUM A/TEXAS (K780277) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HI PRESERUM (K780273) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HI ANTISERUM A/TEXAS (K780276) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HI ANTISERUM (K780274) | Flow Laboratories, Inc. | 1978-02-28 |
| GOAT ANTI-INFLUENZA ANTISERA (K780004) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780006) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780005) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
Track GNS automatically
Every clearance here is in the API, with alerts when new ones post.