FDA 510(k) Application Details - K050367

Device Classification Name	Assay, Heparin   More FDA Info for this Device
510(K) Number	K050367
Device Name	Assay, Heparin
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	864.7525   More FDA Info for this Regulation Number
Classification Product Code	KFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2005
Decision Date	05/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review