illumigene Mycoplasma DNA Amplification Assay— 510(k) K152800

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K152800 for illumigene Mycoplasma DNA Amplification Assay, Substantially Equivalent on 2015-10-23. Applicant: Meridian Bioscience, Inc..

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OZX
Advisory panel: Microbiology
Date received: 2015-09-28
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

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