Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hycor Biomedical , Ltd. · 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) |
|---|---|---|---|---|---|
| K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | Hycor Biomedical , Ltd. | 2005-03-07 | 84 | 0 |
| K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | Hycor Biomedical , Ltd. | 2004-01-20 | 50 | 0 |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | Hycor Biomedical , Ltd. | 2003-05-01 | 52 | 0 |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | Hycor Biomedical , Ltd. | 2003-03-21 | 43 | 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