FDA 510(k) Application Details - K063852

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K063852
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	HOME ACCESS HEALTH CORP. 2401 W. HASSELL SUITE 1510 HOFFMAN ESTATES, IL 60195-5200 US Other 510(k) Applications for this Company
Contact	KAREN L HANSON Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2006
Decision Date	11/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review