FDA 510(k) Application Details - K171976

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K171976
Device Name	Antigens, All Groups, Streptococcus Spp.
Applicant	Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Edward C. Brehm 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	06/30/2017
Decision Date	12/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review