VIDAS THEOPHYLLINE(THEO)— 510(k) K933258

Name: FDA 510(k) clearance K933258
Creator: U.S. Food and Drug Administration
Published: 1993-08-16

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K933258 for VIDAS THEOPHYLLINE(THEO), Substantially Equivalent on 1993-08-16. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1993-07-06
Decision date: 1993-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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