FDA 510(k) Application Details - K192817

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K192817
Device Name	Campylobacter Pylori
Applicant	Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 US Other 510(k) Applications for this Company
Contact	Cathlena Martinez 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	10/01/2019
Decision Date	03/13/2020
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