FDA 510(k) Application Details - K152285

Device Classification Name	More FDA Info for this Device
510(K) Number	K152285
Device Name	illumigene Pertussis DNA Amplification Assay
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	SUSAN ROLIH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2015
Decision Date	11/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review