FDA 510(k) Application Details - K021698

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K021698
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	IMMUNETECH CORPORATION P.O. BOX 9433 17394 VIA DEL BRAVO RANCHO SANTA FE, CA 92067 US Other 510(k) Applications for this Company
Contact	VIVIANNE NOETZEL 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	05/22/2002
Decision Date	09/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review