DJC — Thin Layer Chromatography, Methamphetamine Class II
FDA product code DJC covers "Thin Layer Chromatography, Methamphetamine", a Class II medical device regulated under 21 CFR 862.3610. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DJC
- Device Class
- Class II
- Regulation Number
- 862.3610
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253705 | healgen scientific | Healgen® Accurate Oral Fluid Drug Test | March 16, 2026 |
| K240287 | hangzhou laihe biotech co | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | March 18, 2025 |
| K180878 | shanghai venture bio-tech co | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxaze | December 17, 2018 |
| K181305 | premier biotech | OralTox Oral fluid Drug Test | September 20, 2018 |
| K171403 | premier biotech | OralTox Oral Fluid Drug Test | February 2, 2018 |
| K161044 | assure tech. (hangzhou) co | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split | July 6, 2016 |
| K132630 | guangzhou wondfo biotech co | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (ME | September 27, 2013 |
| K080347 | taiwan unison biotech | UNISCAN -DOA SYSTEM | October 9, 2008 |
| K060355 | acro biotech | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | August 7, 2006 |
| K060896 | varian | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | June 9, 2006 |
| K053033 | acro biotech | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | June 6, 2006 |
| K031497 | amedica biotech | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | October 17, 2003 |
| K022388 | starplex scientific | STARTOX DRUG OF ABUSE SCREENING TEST (4) | February 27, 2003 |
| K022501 | alfa scientific designs | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | November 13, 2002 |
| K022141 | medtox diagnostics | VERDICT-II | July 30, 2002 |
| K011185 | psychemedics | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | January 24, 2002 |
| K013180 | american bio medica | RAPIDONE-ECSTASY TEST | November 26, 2001 |
| K010226 | medtox diagnostics | VERDICT -II METHAMPHETAMINE | June 1, 2001 |
| K002265 | branan medical corporation | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | November 27, 2000 |
| K002587 | branan medical corporation | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | November 22, 2000 |