FDA 510(k) Application Details - K031377

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K031377
Device Name	Instrument, Coagulation, Automated
Applicant	DADE BEHRING, INC. 500 GBC DR. NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2003
Decision Date	09/08/2003
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