Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Euro-Diagnostics BV — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
96 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851332 | BLHI LUTEINIZING HORMONE | Euro-Diagnostics BV | 1985-07-09 | 96 | 0 |
| K851148 | TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE | Euro-Diagnostics BV | 1985-04-29 | 39 | 0 |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Euro-Diagnostics BV | 1985-04-08 | 90 | 0 |
| K843930 | IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I | Euro-Diagnostics BV | 1984-10-30 | 25 | 0 |
| K842478 | PROLACTIN IRMA | Euro-Diagnostics BV | 1984-09-14 | 81 | 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