FDA 510(k) Application Details - K013466

Device Classification Name	Electrophoretic Separation, Lipoproteins   More FDA Info for this Device
510(K) Number	K013466
Device Name	Electrophoretic Separation, Lipoproteins
Applicant	HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	PATRICIA FRANKS 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	10/18/2001
Decision Date	12/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review