Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Molecular Biosystems, 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) |
|---|---|---|---|---|---|
| K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-08-12 | 283 | 0 |
| K873670 | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-06-08 | 271 | 0 |
| K873565 | SNAP(R) ROTAVIRUS DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-05-13 | 254 | 0 |
| K873932 | THE EXTRACTOR(TM) | Molecular Biosystems, Inc. | 1987-11-20 | 56 | 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