510(k) K923286 ยท CGN Acid, Folic, Radioimmunoassay
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
| Applicant | Baxter Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Sep 17, 1992 |
| Received | Jul 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923286
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.