FDA 510(k) Application Details - K050448

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K050448
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE MONTPELLIER, HERAULT 34184 FR Other 510(k) Applications for this Company
Contact	TIM LAWTON 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	02/22/2005
Decision Date	09/23/2005
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