Device Classification Name |
lynch syndrome test system
|
De Novo Number |
DEN170030 |
Device Name |
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody |
Requester |
ventana medical systems |
1910 e. innovation park dr. |
tucson,
AZ
85755
|
|
Contact |
carol "penny" houston |
|
Regulation Number | 864.1866
|
Classification Product Code |
|
Date Received | 05/30/2017 |
Decision Date | 10/27/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Pathology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|