FDA 510(k) Application Details - K080662

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K080662
Device Name	Test, Cystatin C
Applicant	GENZYME CORPORATION 31 NEW YORK AVENUE FRAMINGHAM, MA 01701-9322 US Other 510(k) Applications for this Company
Contact	ERIC LAWSON 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	03/10/2008
Decision Date	05/15/2008
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