510(k) K130470 ยท OZN C. Difficile Toxin Gene Amplification Assay
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
| Applicant | Geneohm Sciences Canada, Inc. (Bd Diagnostics), Quebec, CA |
| Decision | Substantially Equivalent, Apr 2, 2013 |
| Received | Feb 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton Dickinson & Co. BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. Open, Classified |
OZN | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD MAX System, BD MAX Instrument
Version or Model: 441916
Catalog Number: 441916 Open, Classified |
OZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.