FDA 510(k) Application Details - K051968

Device Classification Name	Electrode, Ion Based, Enzymatic, Creatinine   More FDA Info for this Device
510(K) Number	K051968
Device Name	Electrode, Ion Based, Enzymatic, Creatinine
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	LENE MEINECHE MARNAES Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2005
Decision Date	10/16/2006
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