FDA 510(k) Application Details - K070383

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K070383
Device Name	Enzymatic Method, Creatinine
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	DEBBIE M MURRAY 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	02/09/2007
Decision Date	06/22/2007
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