FDA 510(k) Application Details - K953495

Device Classification Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K953495
Device Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant	SCIMEDX CORP. 400 FORD RD. DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	THOMAS BRITTEN Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	DBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/1995
Decision Date	04/10/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review