FDA 510(k) Application Details - K955608

Device Classification Name	Cells, Animal And Human, Cultured   More FDA Info for this Device
510(K) Number	K955608
Device Name	Cells, Animal And Human, Cultured
Applicant	VAI DIAGNOSTICS, INC. 5171 WILFONG RD. MEMPHIS, TN 38134 US Other 510(k) Applications for this Company
Contact	ROBERT F NAEGELE 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	12/08/1995
Decision Date	07/08/1996
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