510(k) K895484 ยท LCD Enzyme Immunoassay, Gentamicin
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Oct 4, 1989 |
| Received | Sep 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895484
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.