510(k) K081063 ยท NGZ Susceptibility Test Plate, Antifungal
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
| Applicant | Trek Diagnostic Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Mar 6, 2009 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081063
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.