FDA 510(k) Application Details - K153661

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K153661
Device Name	Campylobacter Pylori
Applicant	Meridian Bioscience, Inc 3471 River Hills Drive Cincinnati, OH 45244 US Other 510(k) Applications for this Company
Contact	Susan Rolih Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LYR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2015
Decision Date	03/14/2016
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