FDA 510(k) Application Details - K161817

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K161817
Device Name	Test, Cystatin C
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Patrick Stimart 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	07/01/2016
Decision Date	07/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review