Ventana Medical Systems · Class II · Cleared Oct 27, 2017
| K-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 |
| Applicant | Ventana Medical Systems |
| Product code | PZJ |
| Device class | Class II |
| Decision date | Oct 27, 2017 |
| Decision | Not Substantially Equivalent |
| Regulation | 864.1866 |
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