510(k) K831416 ยท LCD Enzyme Immunoassay, Gentamicin
EMIT QST TOBRAMYCIN ASSAY
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 8, 1983 |
| Received | May 3, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831416
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.