Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Accu-Stat Diagnostics, 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) |
|---|---|---|---|---|---|
| K041221 | ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (C | Accu-Stat Diagnostics, Inc. | 2004-07-13 | 64 | 0 |
| K040629 | ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE | Accu-Stat Diagnostics, Inc. | 2004-05-05 | 56 | 0 |
| K040327 | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJU | Accu-Stat Diagnostics, Inc. | 2004-04-19 | 69 | 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