Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alere Technologies AS — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018-11-29 | 31 | 0 |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018-05-07 | 94 | 0 |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015-09-25 | 85 | 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