510(k) K050352 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
| Applicant | Ameritek Research, LLC, Mill Creek WA, US |
| Decision | Substantially Equivalent, Sep 1, 2005 |
| Received | Feb 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050352
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.