FDA 510(k) Application Details - K951461

Device Classification Name	Cells, Animal And Human, Cultured   More FDA Info for this Device
510(K) Number	K951461
Device Name	Cells, Animal And Human, Cultured
Applicant	VIROMED LABORATORIES, INC. 6101 BLUE CIRCLE DR. MINNETONKA, MN 55343-7920 US Other 510(k) Applications for this Company
Contact	BONITA L BASKIN 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	03/30/1995
Decision Date	05/22/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review