FDA 510(k) Application Details - K083906

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K083906
Device Name	Test, Cystatin C
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	KIRA GORDON 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	12/30/2008
Decision Date	03/11/2009
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