FDA 510(k) Application Details - K042890

Device Classification Name	Fibrin Split Products   More FDA Info for this Device
510(K) Number	K042890
Device Name	Fibrin Split Products
Applicant	BIOSITE INCORPORATED 11030 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JEFFERY R DAHLEN Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	GHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2004
Decision Date	11/29/2004
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