DeviceClearance

illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10— 510(k) K151046

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K151046 for illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10, Substantially Equivalent on 2015-07-17. Applicant: Meridian Bioscience, Inc..

Clearance details

Applicant
Meridian Bioscience, Inc.
Product code
Code PGI
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cincinnati, OH, US
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