FDA 510(k) Application Details - K994341

Device Classification Name	Fibrinogen Standard   More FDA Info for this Device
510(K) Number	K994341
Device Name	Fibrinogen Standard
Applicant	DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	REBECCA S AYASH 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	12/23/1999
Decision Date	03/03/2000
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