FDA 510(k) Application Details - K972396

Device Classification Name	Antigens (Febrile), Agglutination, Brucella Spp.   More FDA Info for this Device
510(K) Number	K972396
Device Name	Antigens (Febrile), Agglutination, Brucella Spp.
Applicant	LEE LABORATORIES, INC. 1475 HWY. 78, S.W. GRAYSON, GA 30221 US Other 510(k) Applications for this Company
Contact	ROBIN C HART Other 510(k) Applications for this Contact
Regulation Number	866.3085   More FDA Info for this Regulation Number
Classification Product Code	GSO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/1997
Decision Date	08/25/1997
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