510(k) K232092 ยท OZN C. Difficile Toxin Gene Amplification Assay
Great Basin Toxigenic C. difficile Direct Test (CDF2)
| Applicant | Vela Operations USA, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 14, 2023 |
| Received | Jul 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232092
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.