ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT— 510(k) K123423

Name: FDA 510(k) clearance K123423
Creator: U.S. Food and Drug Administration
Published: 2013-06-05

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K123423 for ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT, Substantially Equivalent on 2013-06-05. Applicant: Meridian Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OZX
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-11-06
Decision date: 2013-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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