FDA 510(k) Application Details - K961547

Device Classification Name	Antisera, All Types, Shigella Spp.   More FDA Info for this Device
510(K) Number	K961547
Device Name	Antisera, All Types, Shigella Spp.
Applicant	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	MARTIN P O'CONNOR Other 510(k) Applications for this Contact
Regulation Number	866.3660   More FDA Info for this Regulation Number
Classification Product Code	GNB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1996
Decision Date	05/20/1996
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