Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leica Biosystems Newcastle, Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | 2023-02-21 | 501 | 0 |
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16 | Leica Biosystems Newcastle, Ltd. | 2020-03-06 | 91 | 0 |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | Leica Biosystems Newcastle, Ltd. | 2014-05-19 | 635 | 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