FDA 510(k) Application Details - K181082

Device Classification Name	Test, Cystatin C   More FDA Info for this Device
510(K) Number	K181082
Device Name	Test, Cystatin C
Applicant	Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, NJ 19714 US Other 510(k) Applications for this Company
Contact	Kathleen Dray-Lyons 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	04/24/2018
Decision Date	05/25/2018
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