FDA 510(k) Application Details - K123793

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K123793
Device Name	Antigens, All Groups, Streptococcus Spp.
Applicant	QUIDEL CORPORATION 10165 MCKELLAR COURT SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN D TAMERIUS, PH.D. 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	12/10/2012
Decision Date	06/17/2013
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