Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orion Diagnostica, Div. Orion Corp. · 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) |
|---|---|---|---|---|---|
| K031607 | ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL | Orion Diagnostica, Div. Orion Corp. | 2003-10-10 | 141 | 0 |
| K022176 | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORI | Orion Diagnostica, Div. Orion Corp. | 2002-12-03 | 153 | 0 |
| K971537 | PYLORISET EIA-G (68926) | Orion Diagnostica, Div. Orion Corp. | 1997-06-27 | 60 | 0 |
| K942974 | PYLORISET DRY | Orion Diagnostica, Div. Orion Corp. | 1995-04-05 | 289 | 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