Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axis-Shield Diagnostics Limited · 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) |
|---|---|---|---|---|---|
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | 2019-08-02 | 269 | 2 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018-12-21 | 147 | 0 |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents a | Axis-Shield Diagnostics Limited | 2016-08-04 | 237 | 0 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, A | Axis-Shield Diagnostics Limited | 2016-07-26 | 130 | 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