FDA 510(k) Application Details - K013662

Device Classification Name	Electrophoretic Separation, Lipoproteins   More FDA Info for this Device
510(K) Number	K013662
Device Name	Electrophoretic Separation, Lipoproteins
Applicant	QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. REDONDO BEACH, CA 90278-1205 US Other 510(k) Applications for this Company
Contact	GEBHARD NEYER Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	JHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2001
Decision Date	03/08/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review