FDA 510(k) Application Details - K012411

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K012411
Device Name	Campylobacter Pylori
Applicant	GI SUPPLY 200 GRANDVIEW AVE. CAMP HILL, PA 17011 US Other 510(k) Applications for this Company
Contact	FRANK CARTER 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	07/30/2001
Decision Date	09/25/2001
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