Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DIT · 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) |
|---|---|---|---|---|---|
| K972577 | QUICK SCREEN ONE STEP AMPHETAMINE TEST | Phamatech | 1997-08-20 | 41 | 0 |
| K910525 | MICROLINE SCREEN FOR METHAMPHETAMINE | Drug Screening Systems, Inc. | 1991-04-05 | 57 | 0 |
| K901276 | HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL | Diagnostic Products Corp. | 1990-04-26 | 38 | 0 |
| K790805 | DRUG ABUSE DIPSTICKS | Technical Resources, Inc. | 1979-06-06 | 42 | 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