FDA 510(k) Application Details - K001177

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K001177
Device Name	Campylobacter Pylori
Applicant	ENTERIC PRODUCTS, INC. 25 EAST LOOP DR. STONY BROOK, NY 11790 US Other 510(k) Applications for this Company
Contact	JEFFREY PEACOCK 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	04/11/2000
Decision Date	11/13/2000
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