Panels › Immunology › Product code PZJ · Class 2
Lynch Syndrome Test System
Regulation 864.1866
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biocartis NV | 1 | 0 |
| Leica Biosystems Newcastle, Ltd. | 1 | 0 |
| Promega Corporation | 1 | 0 |
| Roche Tissue Diagnostics, Inc. | 1 | 0 |
| Ventana Medical Systems | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K260776 | VENTANA MMR IHC Panel Roche Tissue Diagnostics, Inc. | PZJ |
| Feb 27, 2023 | K211181 | Idylla MSI Test Biocartis NV, BE | PZJ |
| Feb 21, 2023 | K213348 | BOND MMR Antibody Panel Leica Biosystems Newcastle, Ltd., GB | PZJ |
| Jul 26, 2021 | K200129 | OncoMate MSI Dx Analysis System Promega Corporation | PZJ |
| Oct 27, 2017 | DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, V Ventana Medical Systems | PZJ |
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