Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GNB · Predicate Candidate Screening
41 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
28 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | Sa Scientific, Inc. | 1996-05-31 | 39 | 0 |
| K961528 | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961529 | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961531 | SAS SHIGELLA BOYDII TYPE 13 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K953316 | SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953317 | SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953318 | SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953319 | SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953320 | SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953321 | SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM | Sa Scientific, Inc. | 1995-08-04 | 22 | 0 |
| K953322 | SAS SHIGELLA BOYDII TYPE 1 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953323 | SAS SHIGELLA BOYDII TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953324 | SAS SHIGELLA BOYDII TYPE 3 ANTISERUN | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953325 | SAS SHIGELLA BOYDII TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953326 | SAS SHIGELLA BOYDII TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953327 | SAS SHIGELLA BOYDII TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953328 | SAS SHIGELLA BOYDII TYPE 7 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K953329 | SAS SHIGELLA BOYDII GROUP C2 ANTISERUM | Sa Scientific, Inc. | 1995-08-02 | 20 | 0 |
| K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 | Wellcome Diagnostics | 1990-01-11 | 127 | 0 |
| K880752 | PHADEBACT SHIGELLA TEST | Pharmacia, Inc. | 1989-02-17 | 359 | 0 |
| K821337 | SHIGELLA I.D. | Analytical Products, Inc. | 1982-05-28 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda