Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cambridge Life Sciences Plc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940700 | AUTOZYME SCREEN | Cambridge Life Sciences Plc. | 1994-06-10 | 114 | 0 |
| K940585 | SELISA ANTI-N DNA ANTIBODIES | Cambridge Life Sciences Plc. | 1994-06-10 | 122 | 0 |
| K922241 | AUTOZYME | Cambridge Life Sciences Plc. | 1992-11-30 | 201 | 0 |
| K891869 | CLS 962 MICROPLATE PHOTOMETER | Cambridge Life Sciences Plc. | 1989-05-09 | 43 | 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