510(k) K921302 ยท JHI Visual, Pregnancy Hcg, Prescription Use
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Jul 28, 1992 |
| Received | Mar 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921302
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.