510(k) K913470 ยท LCD Enzyme Immunoassay, Gentamicin
CEDIA(R) GENTAMICIN ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Aug 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913470
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.