FDA 510(k) Application Details - K073055

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K073055
Device Name	Enzymatic Method, Creatinine
Applicant	DADE BEHRING, INC. P.O. BOX 6101 MS 514 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	VICTOR M CARRIO Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	JFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2007
Decision Date	01/03/2008
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