FDA 510(k) Application Details - K181464

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K181464
Device Name	Campylobacter Pylori
Applicant	DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John C. Walter 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	06/04/2018
Decision Date	08/31/2018
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