FDA 510(k) Application Details - K962146

Device Classification Name	Antisera, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K962146
Device Name	Antisera, All Groups, Streptococcus Spp.
Applicant	EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	MIN-LEE CHENG Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	GTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/1996
Decision Date	10/07/1996
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