FDA 510(k) Application Details - K021398

Device Classification Name	System, Test, Anticardiolipin Immunological   More FDA Info for this Device
510(K) Number	K021398
Device Name	System, Test, Anticardiolipin Immunological
Applicant	LOUISVILLE APL DIAGNOSTICS, INC. 3988 FLOWERS RD., SUITE 620 DORAVILLE, GA 30360 US Other 510(k) Applications for this Company
Contact	SILVIA S PIERANGELI 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	05/02/2002
Decision Date	08/27/2002
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