FDA 510(k) Application Details - K980812

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K980812
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	AXIS BIOCHEMICALS, ASA PO BOX 262069 SAN DIEGO, CA 92196 US Other 510(k) Applications for this Company
Contact	RONALD G LEONARDI, PH.D. 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	03/03/1998
Decision Date	10/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review