510(k) K090968 ยท NGZ Susceptibility Test Plate, Antifungal
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
| Applicant | Trek Diagnostic Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 4, 2009 |
| Received | Apr 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | Remel, Inc Yeastone Broth, 11ML, 10/BOX
YY3462 Open, Classified |
NGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.