FDA 510(k) Application Details - K971909

Device Classification Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K971909
Device Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD. WALTLHAM, MA 02154 US Other 510(k) Applications for this Company
Contact	JOSEPH M CALIFANO Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	DBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/1997
Decision Date	06/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review