PREMIER C. DIFFICILE GDH— 510(k) K110620

Name: FDA 510(k) clearance K110620
Creator: U.S. Food and Drug Administration
Published: 2011-05-03

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K110620 for PREMIER C. DIFFICILE GDH, Substantially Equivalent on 2011-05-03. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code MCB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2011-03-03
Decision date: 2011-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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