OncoMate MSI Dx Analysis System
FDA 510(k) clearance K200129 · decided 2021-07-26
Clearance details
- K-number
- K200129
- Device name
- OncoMate MSI Dx Analysis System
- Applicant
- Promega Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-01-21
- Decision date
- 2021-07-26
- Days to decision
- 552 days
- Clearance type
- Traditional
- Product code
- PZJ
- Device class
- 2
- Regulation number
- 864.1866
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Idylla MSI Test (K211181) | Biocartis NV | 2023-02-27 |
| BOND MMR Antibody Panel (K213348) | Leica Biosystems Newcastle, Ltd. | 2023-02-21 |
| 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 (DEN170030) | Ventana Medical Systems | 2017-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OncoMate® MSI Dx Analysis System (P240026) | Promega Corporation | 2025-11-05 |