FDA 510(k) Application Details - K162540

Device Classification Name	Assay, Heparin   More FDA Info for this Device
510(K) Number	K162540
Device Name	Assay, Heparin
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH EMIL-VON BEHRING STR 76 MARBURG 35041 DE Other 510(k) Applications for this Company
Contact	ROSE T MARINELLI Other 510(k) Applications for this Contact
Regulation Number	864.7525   More FDA Info for this Regulation Number
Classification Product Code	KFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2016
Decision Date	08/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review