FDA 510(k) Application Details - K043264

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K043264
Device Name	System, Test, Low Density, Lipoprotein
Applicant	DENKA SEIKEN CO., LTD. 1-2-2, MINAMIHONCHO GOSEN-SHI, NIIGATA 959-1695 JP Other 510(k) Applications for this Company
Contact	TOSHIMI MATSUNAGA Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2004
Decision Date	01/26/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review