FDA 510(k) Application Details - K970735

Device Classification Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K970735
Device Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	P. ARMSTONG Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/1997
Decision Date	06/06/1997
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