FDA 510(k) Application Details - K151046

Device Classification Name	More FDA Info for this Device
510(K) Number	K151046
Device Name	illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	STEFANIE JOHNS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	07/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review