Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CZX · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-08 | 20 | 0 |
| K790713 | ANTISERUM TO HUMAN HEMOPEXIN | Kent Laboratories, Inc. | 1979-09-04 | 145 | 0 |
| K780250 | HEMOPEXIN NEPHELOMETRIC ASSAYS | Kallestad Laboratories, Inc. | 1978-02-28 | 14 | 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