FDA 510(k) Application Details - K962060

Device Classification Name	Antisera, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K962060
Device Name	Antisera, All Groups, Streptococcus Spp.
Applicant	BIOSTAR, INC. 6655 LOOKOUT RD. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LYNDAL K HESTERBERG 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	05/28/1996
Decision Date	07/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review