FDA 510(k) Applications for Medical Device Product Code "GNB"
(Antisera, All Types, Shigella Spp.)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961546 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | 05/20/1996 |
| K961554 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | 05/20/1996 |
| K961528 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | 05/20/1996 |
| K961529 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | 05/20/1996 |
| K961531 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 13 ANTISERUM | 05/20/1996 |
| K961547 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | 05/20/1996 |
| K961548 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | 05/20/1996 |
| K961541 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | 05/20/1996 |
| K961543 | SA SCIENTIFIC, INC. | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | 05/20/1996 |
| K961535 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | 05/20/1996 |
| K961553 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | 05/20/1996 |
| K961539 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | 05/20/1996 |
| K961551 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | 05/20/1996 |
| K961538 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | 05/20/1996 |
| K961559 | SA SCIENTIFIC, INC. | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | 05/20/1996 |
| K961556 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | 05/20/1996 |
| K961549 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | 05/20/1996 |
| K961558 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | 05/20/1996 |
| K961542 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | 05/20/1996 |
| K961532 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | 05/20/1996 |
| K961533 | SA SCIENTIFIC, INC. | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | 05/20/1996 |
| K961534 | SA SCIENTIFIC, INC. | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | 05/20/1996 |
| K961537 | SA SCIENTIFIC, INC. | SAS SHIGELLA SONNEI FORM II ANTISERUM | 05/31/1996 |
| K961540 | SA SCIENTIFIC, INC. | SAS SHIGELLA SONNEI GROUP D ANTISERUM | 05/20/1996 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
