FDA 510(k) Application Details - K011097

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K011097
Device Name	Antigens, All Groups, Streptococcus Spp.
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	866.3740   More FDA Info for this Regulation Number
Classification Product Code	GTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2001
Decision Date	05/08/2001
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