FDA 510(k) Application Details - K993669

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K993669
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	DIASORIN, INC. 9175 GUIFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	JUDITH J SMITH Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	DFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/1999
Decision Date	11/17/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review