FDA 510(k) Application Details - K970239

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K970239
Device Name	Extractable Antinuclear Antibody, Antigen And Control
Applicant	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US Other 510(k) Applications for this Company
Contact	LYNNE STIRLING, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/1997
Decision Date	04/08/1997
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