VIDAS ESTRADIOL II (E2II) ASSAY— 510(k) K955647
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K955647 for VIDAS ESTRADIOL II (E2II) ASSAY, Substantially Equivalent on 1996-02-06. Applicant: Biomerieux Vitek, Inc.. Device class: 1.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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More clearances from Biomerieux Vitek, Inc.
view allRecalls naming K955647
K-number listed on FDA's recall record- Z-0867-2023 — VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
- Z-1801-2017 — 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 quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955647.
Data sourced from openFDA. This site is unofficial and independent of the FDA.