illumigene Pertussis DNA Amplification Assay— 510(k) K152285

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K152285 for illumigene Pertussis DNA Amplification Assay, Substantially Equivalent on 2015-11-10. Applicant: Meridian Bioscience, Inc..

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OZZ
Advisory panel: Microbiology
Date received: 2015-08-12
Decision date: 2015-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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