FDA 510(k) Application Details - K973369

Device Classification Name	Ldl & Vldl Precipitation, Hdl   More FDA Info for this Device
510(K) Number	K973369
Device Name	Ldl & Vldl Precipitation, Hdl
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 SOMERVILLE, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	JAMES W HAYNES Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1997
Decision Date	11/21/1997
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