FDA 510(k) Application Details - K991747

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K991747
Device Name	Campylobacter Pylori
Applicant	QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Robin Weiner 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	05/21/1999
Decision Date	08/04/1999
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