FDA 510(k) Application Details - K040437

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K040437
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	BIOSITE INCORPORATED 11030 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JEFFREY R DAHLEN 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	02/19/2004
Decision Date	06/25/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review