FDA 510(k) Application Details - K991697

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K991697
Device Name	Campylobacter Pylori
Applicant	TRINITY BIOTECH, PLC 575 Shirlynn Court Los Altos, CA 94022 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati 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	05/18/1999
Decision Date	12/21/1999
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