FDA Product Code
FDA Product Code PZJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 864.1866
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211181 | Idylla MSI Test | Biocartis NV | 2023-02-27 | Traditional | PDF ↗ |
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | 2023-02-21 | Traditional | PDF ↗ |
| K200129 | OncoMate MSI Dx Analysis System | Promega Corporation | 2021-07-26 | Traditional | PDF ↗ |
| DEN170030 | 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 | Ventana Medical Systems | 2017-10-27 | Direct | — |
Product code PZJ · Class II · Immunology. Data: openFDA.