FDA 510(k) Application Details - K093137

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K093137
Device Name	Test, Cystatin C
Applicant	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US Other 510(k) Applications for this Company
Contact	SHAWN KAPLAN 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	10/05/2009
Decision Date	09/28/2010
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