VIDAS CHLAMYDIA BLOCKING ASSAY— 510(k) K955627

Name: FDA 510(k) clearance K955627
Creator: U.S. Food and Drug Administration
Published: 1996-10-07

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K955627 for VIDAS CHLAMYDIA BLOCKING ASSAY, Substantially Equivalent on 1996-10-07. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1995-12-11
Decision date: 1996-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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