FDA 510(k) Application Details - K962836

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K962836
Device Name	System, Test, Rheumatoid Factor
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	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/1996
Decision Date	09/12/1996
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