Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cambridge Diagnostics Ireland, Ltd. — 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) |
|---|---|---|---|---|---|
| K013907 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Cambridge Diagnostics Ireland, Ltd. | 2001-12-18 | 22 | 0 |
| K970761 | LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTI | Cambridge Diagnostics Ireland, Ltd. | 1998-04-09 | 402 | 0 |
| K970768 | HUMAN LYME IGM WESTERN BLOT KIT | Cambridge Diagnostics Ireland, Ltd. | 1998-04-09 | 402 | 0 |
| K955903 | SELFCARE EARLY PREGNANCY TEST | Cambridge Diagnostics Ireland, Ltd. | 1996-03-06 | 68 | 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