510(k) K955647 ยท CHP Radioimmunoassay, Estradiol
VIDAS ESTRADIOL II (E2II) ASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Feb 6, 1996 |
| Received | Dec 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 Open, Classified |
CHP | None listed |
| Mar 20, 2017 | BioMerieux SA VIDAS Estradiol II, Ref 30431-01, 60 tests
The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantit Terminated |
CHP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.