FDA 510(k) Application Details - K014038

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K014038
Device Name	Campylobacter Pylori
Applicant	SERIM RESEARCH CORP. 23565 REEDY DR. ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	PATRICIA RUPUCHOCK 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	12/07/2001
Decision Date	02/08/2002
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