VIDAS TOTAL IGE (IGE) ASSAY— 510(k) K931224

Name: FDA 510(k) clearance K931224
Creator: U.S. Food and Drug Administration
Published: 1993-05-20

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K931224 for VIDAS TOTAL IGE (IGE) ASSAY, Substantially Equivalent on 1993-05-20. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code DGP
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1993-03-10
Decision date: 1993-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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