Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cheshire Diagnostics , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
57 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021610 | QAB2A IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | 57 | 0 |
| K021611 | QAB2A IGG ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | 57 | 0 |
| K021192 | QACA IGG/IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-05-16 | 31 | 0 |
| K020695 | QAB2A IGG ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-04-19 | 46 | 0 |
| K020694 | QAB2A IGM ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-04-19 | 46 | 0 |
| K020241 | QACA IGG/IGM ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-03-13 | 49 | 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