VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM— 510(k) K921176

Name: FDA 510(k) clearance K921176
Creator: U.S. Food and Drug Administration
Published: 1992-04-08

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K921176 for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, Substantially Equivalent on 1992-04-08. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1992-03-11
Decision date: 1992-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K921176

K-number listed on FDA's recall record

Z-0865-2023 — VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01Class II·Ongoing·Biomerieux Inc·20221109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K921176.

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