Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Ireland Diagnostics Division — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
449 daysmedian FDA review time
568 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | 2023-07-21 | 266 | 0 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 | 59 | 0 |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | 2022-06-30 | 568 | 0 |
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | 2022-05-31 | 524 | 0 |
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | 2022-05-26 | 449 | 0 |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022-03-22 | 399 | 0 |
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | 2022-03-18 | 471 | 0 |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | 2021-11-23 | 384 | 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