FDA 510(k) Application Details - K953686

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K953686
Device Name	Campylobacter Pylori
Applicant	CORTECS, LTD. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF 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	07/31/1995
Decision Date	05/21/1996
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