Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtox Diagnostics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
195 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 | 157 | 0 |
| K100951 | MEDTOX BUPRENORPHINE TEST | Medtox Diagnostics, Inc. | 2010-10-18 | 195 | 0 |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS | Medtox Diagnostics, Inc. | 2010-04-05 | 90 | 0 |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | Medtox Diagnostics, Inc. | 2009-07-24 | 67 | 0 |
| K080635 | MEDTOXSCAN | Medtox Diagnostics, Inc. | 2009-02-13 | 344 | 1 |
| K060351 | MEDTOX OXYCODONE | Medtox Diagnostics, Inc. | 2006-05-12 | 88 | 0 |
| K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHET | Medtox Diagnostics, Inc. | 2005-10-25 | 251 | 0 |
| K033334 | PROFILE -ER | Medtox Diagnostics, Inc. | 2003-11-10 | 25 | 0 |
| K031032 | VERDICT II, PROFILE II | Medtox Diagnostics, Inc. | 2003-07-14 | 104 | 0 |
| K022141 | VERDICT-II | Medtox Diagnostics, Inc. | 2002-07-30 | 28 | 0 |
| K020787 | VERDICT-II PROPOXYPHENE | Medtox Diagnostics, Inc. | 2002-05-02 | 52 | 0 |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | Medtox Diagnostics, Inc. | 2001-06-08 | 21 | 0 |
| K010226 | VERDICT -II METHAMPHETAMINE | Medtox Diagnostics, Inc. | 2001-06-01 | 128 | 0 |
| K010959 | VERDICT -II BAR; VERDICT -II BZO | Medtox Diagnostics, Inc. | 2001-04-13 | 14 | 0 |
| K010564 | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; P | Medtox Diagnostics, Inc. | 2001-04-05 | 38 | 0 |
| K010561 | VERDICT -II BAR/BZO | Medtox Diagnostics, Inc. | 2001-04-05 | 38 | 0 |
| K010138 | PROFILE II ER | Medtox Diagnostics, Inc. | 2001-02-14 | 28 | 0 |
| K002331 | PROFILE-ER | Medtox Diagnostics, Inc. | 2001-01-17 | 169 | 0 |
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II | Medtox Diagnostics, Inc. | 2000-12-22 | 22 | 0 |
| K002776 | MODIFICATION TO PROFILE -II | Medtox Diagnostics, Inc. | 2000-09-28 | 22 | 0 |
| K992111 | VERDICT -II OPIATES 2000 | Medtox Diagnostics, Inc. | 1999-12-16 | 177 | 0 |
| K982211 | PROFILE-II MODEL 600582 | Medtox Diagnostics, Inc. | 1998-07-29 | 36 | 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