Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lee Laboratories, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
60 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972391 | VISTA ANTIGEN SALMONELLA H B | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972389 | VISTA ANTIGEN SALMONELLA H D | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972392 | VISTA ANTIGEN SALMONELLA H A | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972390 | VISTA ANTIGEN SALMONELLA H C | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972394 | VISTA ANTIGEN BRUCELLA ABORTUS | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972396 | VISTA ANTIGEN BRUCELLA MELITENSIS | Lee Laboratories, Inc. | 1997-08-25 | 60 | 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