Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DKN · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914468 | ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES | Roche Diagnostic Systems, Inc. | 1991-10-30 | 23 | 0 |
| K881816 | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES | Roche Diagnostic Systems, Inc. | 1988-07-28 | 91 | 0 |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Hoffmann-La Roche, Inc. | 1983-03-10 | 23 | 0 |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | 66 | 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