510(k) K172569 ยท OZN C. Difficile Toxin Gene Amplification Assay
GenePOC CDiff
| Applicant | Genepoc, Inc., Quebec, CA |
| Decision | Substantially Equivalent, Nov 22, 2017 |
| Received | Aug 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2026 | Meridian Bioscience Inc Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 Open, Classified |
OZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.