Thin Layer Chromatography, Methamphetamine
FDA product code DJC · Class II (moderate risk) · 21 CFR 862.3610 · Clinical Toxicology
31510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Alfa Scientific Designs, Inc. 3
- Cordis Corp. 2
- Premier Biotech, Inc. 2
- Branan Medical Corp. 2
- Medtox Diagnostics, Inc. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Acro Biotech, LLC 2
- American Bio Medica Corp. 1
- Healgen Scientific,, LLC 1
- Assure Tech. (Hangzhou) Co, Ltd. 1
- Guangzhou Wondfo Biotech Co., Ltd. 1
- Taiwan Unison Biotech, Inc. 1
- Varian, Inc. 1
- Amedica Biotech, Inc. 1
- Starplex Scientific, Inc. 1
- Psychemedics Corp. 1
- Roche Diagnostics Corp. 1
- Redwood Biotech, Inc. 1
- Physio-Control Corp. 1
- Cutler Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K053033 | Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000DJC · Traditional | Acro Biotech, LLC | 06/06/2006SE |
| K031497 | Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca TestDJC · Traditional | Amedica Biotech, Inc. | 10/17/2003SE |
| K022388 | Startox Drug of Abuse Screening Test (4)DJC · Traditional | Starplex Scientific, Inc. | 02/27/2003SE |
| K022501 | Instant-View Mdma (Ecstasy, XTC) Urine TestDJC · Abbreviated | Alfa Scientific Designs, Inc. | 11/13/2002SE |
| K022141 | Verdict-IiDJC · Special | Medtox Diagnostics, Inc. | 07/30/2002SE |
| K011185 | Psychemedics Ria Methamphetamine and Mdma AssayDJC · Traditional | Psychemedics Corp. | 01/24/2002SE |
| K013180 | Rapidone-Ecstasy TestDJC · Traditional | American Bio Medica Corp. | 11/26/2001SE |
| K010226 | Verdict -Ii MethamphetamineDJC · Traditional | Medtox Diagnostics, Inc. | 06/01/2001SE |
| K002265 | Branan Medical Corporation Monitect Methamphetamine Drug Screen TestDJC · Traditional | Branan Medical Corporation | 11/27/2000SE |
| K002587 | Branan Medical Corporation Monitect Methamphetamine 500 Drug Screen TestDJC · Traditional | Branan Medical Corporation | 11/22/2000SE |
| K994406 | Instant-View Methamphetamine Urine Dip Strip TestDJC · Traditional | Alfa Scientific Designs, Inc. | 08/14/2000SE |
| K994400 | Instant-View Methamphetamine Urine Cassette TestDJC · Traditional | Alfa Scientific Designs, Inc. | 08/04/2000SE |
| K001356 | Ontrak Testcup PRO-5, Model 1986678DJC · Special | Roche Diagnostics Corp. | 07/10/2000SE |
| K993100 | Redi-ScreenDJC · Special | Redwood Biotech, Inc. | 10/06/1999SE |
| K781156 | Dialysis Sys., PDS 400 & Ro 400DJC · Traditional | Physio-Control Corp. | 10/24/1978SE |
| K781153 | Kidney, ArtificialDJC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/17/1978SE |
| K781140 | Cutter Resiflex Foley CathetersDJC · Traditional | Cutler Laboratories, Inc. | 09/07/1978SE |
| K781238 | Kidney, Artificial, C-Dak 1.5DJC · Traditional | Cordis Corp. | 08/31/1978SE |
| K781237 | Kidney, Artificial, C-Dak 2.0DJC · Traditional | Cordis Corp. | 08/31/1978SE |
| K781110 | Bandage, Compression, FistulaidDJC · Traditional | Medical Device Laboratories | 08/18/1978SE |
| K781331 | A-V Fistula NeedleDJC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/17/1978SE |