510(k) K891385 ยท DEW Igg, Antigen, Antiserum, Control
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Apr 18, 1989 |
| Received | Mar 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891385
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.