FDA 510(k) Application Details - K112818

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K112818
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US Other 510(k) Applications for this Company
Contact	VERONICA DAENZER 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	09/28/2011
Decision Date	07/31/2012
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