FDA 510(k) Application Details - K160829

Device Classification Name	More FDA Info for this Device
510(K) Number	K160829
Device Name	illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	MICHELLE L. SMITH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2016
Decision Date	06/13/2016
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