510(k) K040560 ยท NGZ Susceptibility Test Plate, Antifungal
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jul 27, 2004 |
| Received | Mar 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 Open, Classified |
NGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.