Device Classification Name |
Kappa, Peroxidase, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K940242 |
Device Name |
Kappa, Peroxidase, Antigen, Antiserum, Control |
Applicant |
VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON, AZ 85705 US
Other 510(k) Applications for this Company
|
Contact |
KATHLEEN WINDALL
Other 510(k) Applications for this Contact |
Regulation Number |
866.5550
More FDA Info for this Regulation Number |
Classification Product Code |
DFD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/19/1994 |
Decision Date |
12/23/1996 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|