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
FDA 510(k) clearance DEN170030 · decided 2017-10-27
Clearance details
- 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
- Decision
- Unknown
- Date received
- 2017-05-30
- Decision date
- 2017-10-27
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- PZJ
- Device class
- 2
- Regulation number
- 864.1866
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VENTANA anti-MSH6 (SP93) Antibody (P200019/S013) | Ventana Medical Systems | 2026-01-06 |
| VENTANA MMR RxDx Panel (P200019/S012) | Ventana Medical Systems | 2025-06-20 |
| VENTANA MMR RxDx Panel (P200019/S011) | Ventana Medical Systems | 2025-04-17 |
| VENTANA MMR RxDx Panel (P200019/S010) | Ventana Medical Systems | 2024-12-20 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S009) | Ventana Medical Systems | 2024-01-26 |
| VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM (P200019/S008) | Ventana Medical Systems | 2023-11-08 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S007) | Ventana Medical Systems | 2023-08-29 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S006) | Ventana Medical Systems | 2022-11-10 |