VIDAS C. DIFFICILE TOXIN A II ASSAY— 510(k) K964887

Name: FDA 510(k) clearance K964887
Creator: U.S. Food and Drug Administration
Published: 1997-04-08

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K964887 for VIDAS C. DIFFICILE TOXIN A II ASSAY, Substantially Equivalent on 1997-04-08. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-12-06
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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