FDA 510(k) Application Details - K100818

Device Classification Name	More FDA Info for this Device
510(K) Number	K100818
Device Name	ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. 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	OMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2010
Decision Date	07/09/2010
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