Panels › Microbiology › Product code GNB · Class 2
Antisera, All Types, Shigella Spp.
Regulation 866.3660
0510(k)s in 12 months (41 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in GNB
| Company | 510(k)s | Recalls |
|---|---|---|
| Sa Scientific, Inc. | 38 | 0 |
| Becton Dickinson & Co. | 0 | 2 |
| Analytical Products, Inc. | 1 | 0 |
| Pharmacia, Inc. | 1 | 0 |
| Remel Inc | 0 | 1 |
| Wellcome Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 1996 | K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961531 | SAS SHIGELLA BOYDII TYPE 13 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961529 | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961528 | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953321 | SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953320 | SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953319 | SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953318 | SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953317 | SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 4, 1995 | K953316 | SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953329 | SAS SHIGELLA BOYDII GROUP C2 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953328 | SAS SHIGELLA BOYDII TYPE 7 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953327 | SAS SHIGELLA BOYDII TYPE 6 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953326 | SAS SHIGELLA BOYDII TYPE 5 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953325 | SAS SHIGELLA BOYDII TYPE 4 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953324 | SAS SHIGELLA BOYDII TYPE 3 ANTISERUN Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953323 | SAS SHIGELLA BOYDII TYPE 2 ANTISERUM Sa Scientific, Inc. | GNB |
| Aug 2, 1995 | K953322 | SAS SHIGELLA BOYDII TYPE 1 ANTISERUM Sa Scientific, Inc. | GNB |
| Jan 11, 1990 | K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 Wellcome Diagnostics | GNB |
| Feb 17, 1989 | K880752 | PHADEBACT SHIGELLA TEST Pharmacia, Inc. | GNB |
| May 28, 1982 | K821337 | SHIGELLA I.D. Analytical Products, Inc. | GNB |
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