Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elite Diagnostic , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
59 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT | Elite Diagnostic , Ltd. | 1989-04-21 | 43 | 0 |
| K890859 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME | Elite Diagnostic , Ltd. | 1989-04-21 | 59 | 0 |
| K891179 | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 | 35 | 0 |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | 1989-04-10 | 35 | 0 |
| K890619 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | Elite Diagnostic , Ltd. | 1989-03-15 | 36 | 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