Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osmetech Molecular Diagnostics — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPIN | Osmetech Molecular Diagnostics | 2010-04-22 | 120 | 0 |
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC F | Osmetech Molecular Diagnostics | 2009-07-06 | 96 | 0 |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Osmetech Molecular Diagnostics | 2008-07-17 | 199 | 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