FDA 510(k) Application Details - K012053

Device Classification Name	System, Test, Anticardiolipin Immunological   More FDA Info for this Device
510(K) Number	K012053
Device Name	System, Test, Anticardiolipin Immunological
Applicant	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US Other 510(k) Applications for this Company
Contact	LYNNE STIRLING Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2001
Decision Date	08/20/2001
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