Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PZJ — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211181 | Idylla MSI Test | Biocartis NV | 2023-02-27 | 678 | 0 |
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | 2023-02-21 | 501 | 0 |
| K200129 | OncoMate MSI Dx Analysis System | Promega Corporation | 2021-07-26 | 552 | 0 |
| DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VE | Ventana Medical Systems | 2017-10-27 | 150 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda