VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY— 510(k) K905211

Name: FDA 510(k) clearance K905211
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K905211 for VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY, Substantially Equivalent on 1991-10-11. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1990-11-20
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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