FDA 510(k) Application Details - K982848

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K982848
Device Name	System, Test, Low Density, Lipoprotein
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	MARIA FEIJOO 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	08/12/1998
Decision Date	10/01/1998
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