FDA 510(k) Application Details - K072304

Device Classification Name	Fibrinogen Standard   More FDA Info for this Device
510(K) Number	K072304
Device Name	Fibrinogen Standard
Applicant	DADE BEHRING, INC. P.O. BOX 6101; MS 514 GLASGOW BLDG. 500 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO Other 510(k) Applications for this Contact
Regulation Number	864.7340   More FDA Info for this Regulation Number
Classification Product Code	GFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2007
Decision Date	09/19/2007
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