FDA 510(k) Application Details - K073072

Device Classification Name	Colorimetric Method, Lipoproteins   More FDA Info for this Device
510(K) Number	K073072
Device Name	Colorimetric Method, Lipoproteins
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	PAMELA A JURGA 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	10/31/2007
Decision Date	02/21/2008
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