510(k) K874438 ยท LEH Radioimmunoassay, Vancomycin
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Jan 21, 1988 |
| Received | Oct 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874438
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.