FDA 510(k) Application Details - K061979

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K061979
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	IMMUNETECH CORPORATION 888 OAK GROVE, SUITE 4 MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	NANCY BENSON 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	07/13/2006
Decision Date	09/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review