FDA 510(k) Application Details - K062105

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K062105
Device Name	Enzymatic Method, Creatinine
Applicant	DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Abhijit Datta 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	07/24/2006
Decision Date	04/23/2007
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