FDA 510(k) Application Details - K965047

Device Classification Name	Cells, Animal And Human, Cultured   More FDA Info for this Device
510(K) Number	K965047
Device Name	Cells, Animal And Human, Cultured
Applicant	NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 EVERETT, WA 98204 US Other 510(k) Applications for this Company
Contact	E. WILLIAM RADANY, PH.D. Other 510(k) Applications for this Contact
Regulation Number	864.2280   More FDA Info for this Regulation Number
Classification Product Code	KIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/1996
Decision Date	02/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review