FDA 510(k) Application Details - K072270

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K072270
Device Name	Test, Cystatin C
Applicant	DIAZYME LABORATORIES 12889 GREGG COURT POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	CHARLES YU Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	NDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2007
Decision Date	02/01/2008
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