FDA 510(k) Application Details - K061412

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K061412
Device Name	Enzymatic Method, Creatinine
Applicant	THERMO ELECTRON CORP. 171 INDUSTRY DRIVE PITTSBURG, PA 15272 US Other 510(k) Applications for this Company
Contact	BOLA NICHOLSON 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	05/22/2006
Decision Date	03/23/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review