GNS — Antisera, Hai, Influenza Virus A, B, C Class I
FDA product code GNS covers "Antisera, Hai, Influenza Virus A, B, C", a Class I medical device regulated under 21 CFR 866.3330. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNS
- Device Class
- Class I
- Regulation Number
- 866.3330
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K780697 | Northeast Biomedical Labs | GOAT ANTI-INFLUENZA ANTISERA ATEXAS | May 3, 1978 |
| K780696 | Northeast Biomedical Labs | GOAT ANTIINFLUENZA ANTISERA AUSSR | May 3, 1978 |
| K780277 | Flow Laboratories | INFLUENZA HI PRESERUM A/TEXAS | Feb 28, 1978 |
| K780273 | Flow Laboratories | INFLUENZA HI PRESERUM | Feb 28, 1978 |
| K780276 | Flow Laboratories | INFLUENZA HI ANTISERUM A/TEXAS | Feb 28, 1978 |
| K780274 | Flow Laboratories | INFLUENZA HI ANTISERUM | Feb 28, 1978 |
| K780005 | Northeast Biomedical Labs | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 |
| K780006 | Northeast Biomedical Labs | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 |
| K780004 | Northeast Biomedical Labs | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 |