Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotrax, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | 1991-07-24 | 295 | 0 |
| K904416 | CROATEST (R) RHEUMATOID DIAGNOSTIC | Biotrax, Inc. | 1991-06-24 | 270 | 0 |
| K904497 | CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST | Biotrax, Inc. | 1990-11-01 | 30 | 0 |
| K904498 | CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST | Biotrax, Inc. | 1990-10-29 | 27 | 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