FDA 510(k) Application Details - K032798

Device Classification Name	Colorimetric Method, Lipoproteins   More FDA Info for this Device
510(K) Number	K032798
Device Name	Colorimetric Method, Lipoproteins
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ANDREA M TASKER Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	JHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2003
Decision Date	10/30/2003
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