FDA 510(k) Application Details - K960183

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K960183
Device Name	Campylobacter Pylori
Applicant	SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. SAN JOSE, CA 95134-1622 US Other 510(k) Applications for this Company
Contact	MARSHALL C MCCARTY 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	01/16/1996
Decision Date	06/07/1996
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