510(k) K991597 ยท LGJ Fluorescence Polarization Immunoassay, Amibacin
COBAS INTEGRA AMIKACIN MAB
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 22, 1999 |
| Received | May 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991597
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.