Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serex, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
91 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Serex, Inc. | 1992-08-24 | 48 | 0 |
| K921834 | AUTOMATES COMA COCAINE METABOLITE ASSAY | Serex, Inc. | 1992-06-15 | 60 | 0 |
| K901333 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1990-04-02 | 13 | 0 |
| K895043 | COMA COCAINE METABOLITE ASSAY (EIA) | Serex, Inc. | 1989-11-08 | 91 | 0 |
| K890694 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1989-03-16 | 34 | 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