Verdict-Ii
FDA 510(k) K022141 · Medtox Diagnostics, Inc.
510(k) numberK022141
Submission
- Device name
- Verdict-Ii
- Applicant
- Medtox Diagnostics, Inc.
Burlington, NC, US - Received
- July 2, 2002
- Decision date
- July 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | Healgen Scientific,, LLC | 03/16/2026SE |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 03/18/2025SE |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…DJC · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/17/2018SE |
| K181305 | OralTox Oral fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 09/20/2018SE |
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 02/02/2018SE |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 07/06/2016SE |
| K132630 | Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)DJC · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/27/2013SE |
| K080347 | Uniscan -Doa SystemDJC · Traditional | Taiwan Unison Biotech, Inc. | 10/09/2008SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
More from Varian, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | 01/29/2026SE |
| K100951 | Medtox Buprenorphine TestDJG · Traditional | 10/18/2010SE |
| K100023 | Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemDJG · Traditional | 04/05/2010SE |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemDJG · Traditional | 07/24/2009SE |
| K080635 | MedtoxscanDKZ · Traditional | 02/13/2009SE |
| K060351 | Medtox OxycodoneDJG · Traditional | 05/12/2006SE |
| K050394 | Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone…DKZ · Traditional | 10/25/2005SE |
| K033334 | Profile -ErDIS · Special | 11/10/2003SE |
| K031032 | Verdict II, Profile IIDJG · Special | 07/14/2003SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | 05/02/2002SE |
Questions and answers
When was Verdict-Ii cleared by the FDA?
Verdict-Ii (K022141) received a 510(k) decision of Substantially Equivalent on July 30, 2002, 28 days after the submission was received.
What is the product code of K022141?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.