ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920— 510(k) K100818

Name: FDA 510(k) clearance K100818
Creator: U.S. Food and Drug Administration
Published: 2010-07-09

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K100818 for ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920, Substantially Equivalent on 2010-07-09. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OMN
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2010-03-23
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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