FDA 510(k) Application Details - K965099

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K965099
Device Name	Campylobacter Pylori
Applicant	CHEMTRAK, INC. 929 EAST ARQUES AVE. SUNNYVALE, CA 94086-4520 US Other 510(k) Applications for this Company
Contact	RODGER J RICHEAL 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	12/20/1996
Decision Date	02/20/1997
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