FDA 510(k) Application Details - K043007

Device Classification Name	Antithrombin Iii Quantitation   More FDA Info for this Device
510(K) Number	K043007
Device Name	Antithrombin Iii Quantitation
Applicant	HYPHEN BIOMED 6560 GOVE CT. MASON, OH 45040 US Other 510(k) Applications for this Company
Contact	OLA ANDERSON Other 510(k) Applications for this Contact
Regulation Number	864.7060   More FDA Info for this Regulation Number
Classification Product Code	JBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2004
Decision Date	11/07/2005
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