FDA 510(k) Application Details - K062530

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K062530
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	FIL V BUENVIAJE 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	08/29/2006
Decision Date	01/29/2007
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