Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leica Biosystems Newcastle, Limited · 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) |
|---|---|---|---|---|---|
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Recept | Leica Biosystems Newcastle, Limited | 2018-12-07 | 30 | 0 |
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody f | Leica Biosystems Newcastle, Limited | 2018-12-07 | 30 | 0 |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Recept | Leica Biosystems Newcastle, Limited | 2017-07-21 | 39 | 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