GNB — Antisera, All Types, Shigella Spp. Class II
FDA product code GNB covers "Antisera, All Types, Shigella Spp.", a Class II medical device regulated under 21 CFR 866.3660. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNB
- Device Class
- Class II
- Regulation Number
- 866.3660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961537 | sa scientific | SAS SHIGELLA SONNEI FORM II ANTISERUM | May 31, 1996 |
| K961528 | sa scientific | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | May 20, 1996 |
| K961556 | sa scientific | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | May 20, 1996 |
| K961554 | sa scientific | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | May 20, 1996 |
| K961535 | sa scientific | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | May 20, 1996 |
| K961548 | sa scientific | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | May 20, 1996 |
| K961551 | sa scientific | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | May 20, 1996 |
| K961553 | sa scientific | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | May 20, 1996 |
| K961529 | sa scientific | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | May 20, 1996 |
| K961542 | sa scientific | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | May 20, 1996 |
| K961540 | sa scientific | SAS SHIGELLA SONNEI GROUP D ANTISERUM | May 20, 1996 |
| K961547 | sa scientific | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | May 20, 1996 |
| K961534 | sa scientific | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | May 20, 1996 |
| K961549 | sa scientific | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | May 20, 1996 |
| K961538 | sa scientific | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | May 20, 1996 |
| K961539 | sa scientific | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | May 20, 1996 |
| K961533 | sa scientific | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | May 20, 1996 |
| K961546 | sa scientific | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | May 20, 1996 |
| K961541 | sa scientific | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | May 20, 1996 |
| K961532 | sa scientific | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | May 20, 1996 |