Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orion Diagnostica, OY · 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) |
|---|---|---|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead | Orion Diagnostica, OY | 2016-03-10 | 511 | 0 |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | Orion Diagnostica, OY | 2005-05-04 | 173 | 0 |
| K042625 | QUIKREAD CRP CALIBRATOR SET | Orion Diagnostica, OY | 2004-11-18 | 52 | 0 |
| K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD | Orion Diagnostica, OY | 2004-09-24 | 15 | 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