FDA 510(k) Application Details - K071388

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K071388
Device Name	Test, Cystatin C
Applicant	GENTIAN AS 9915 CAM. CHIRIMOLLA SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	RONALD G LEONARDI 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	05/18/2007
Decision Date	11/06/2007
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