Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Drug Testing, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
140 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940912 | USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 | U.S. Drug Testing, Inc. | 1994-06-02 | 97 | 0 |
| K935629 | USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 | U.S. Drug Testing, Inc. | 1994-04-12 | 140 | 0 |
| K934693 | AMPHETAMINE TEST SYSTEM | U.S. Drug Testing, Inc. | 1993-11-22 | 53 | 0 |
| K932318 | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 | U.S. Drug Testing, Inc. | 1993-06-15 | 35 | 0 |
| K931227 | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | U.S. Drug Testing, Inc. | 1993-05-06 | 57 | 0 |
| K930985 | USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 | U.S. Drug Testing, Inc. | 1993-04-27 | 61 | 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