VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT— 510(k) K931031

Name: FDA 510(k) clearance K931031
Creator: U.S. Food and Drug Administration
Published: 1993-07-27

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K931031 for VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT, Substantially Equivalent on 1993-07-27. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code JFT
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1993-03-01
Decision date: 1993-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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