FDA 510(k) Application Details - K172903

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K172903
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730-4207 US Other 510(k) Applications for this Company
Contact	Shajunath Nirupama Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	DAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2017
Decision Date	11/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review