Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abx, Inc. — 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) |
|---|---|---|---|---|---|
| K962633 | VEGA HEMATOLOGY ANALYZER | Abx, Inc. | 1996-11-04 | 122 | 0 |
| K895127 | ARGOS | Abx, Inc. | 1989-10-10 | 54 | 0 |
| K880616 | MINOS AUTOMATIC CELL COUNTER | Abx, Inc. | 1988-05-02 | 76 | 0 |
| K864579 | MINOS AUTOMATIC CELL COUNTER | Abx, Inc. | 1987-07-16 | 238 | 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