VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM— 510(k) K923122

Name: FDA 510(k) clearance K923122
Creator: U.S. Food and Drug Administration
Published: 1992-10-26

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K923122 for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, Substantially Equivalent on 1992-10-26. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1992-06-26
Decision date: 1992-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K923122

K-number listed on FDA's recall record

Z-0795-2023 — VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217Class II·Ongoing·Biomerieux Inc·20221109
Z-1107-2020 — VIDAS Varicella Zoster IgG (VZG) antibody IVD, kitClass II·Terminated·bioMerieux, Inc.·20191210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923122.

Data sourced from openFDA. This site is unofficial and independent of the FDA.