FDA 510(k) Application Details - K050365

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K050365
Device Name	Test, Qualitative And Quantitative Factor Deficiency
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	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2005
Decision Date	12/27/2005
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