Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diatron U.S., Inc. — 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) |
|---|---|---|---|---|---|
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, | Diatron U.S., Inc. | 2016-01-14 | 226 | 0 |
| K111534 | ABACUS 3CP | Diatron U.S., Inc. | 2012-08-02 | 427 | 0 |
| K112755 | ABACUS 5 | Diatron U.S., Inc. | 2012-03-27 | 188 | 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