510(k) K801308 ยท LCR Fluorescent Immunoassay, Tobramycin
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
| Applicant | Intl. Diagnostic Technology, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 20, 1980 |
| Received | Jun 3, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801308
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.