DJC — Thin Layer Chromatography, Methamphetamine Class II
FDA Device Classification
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 |
|---|
| 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 |
| K994406 | alfa scientific designs | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | August 14, 2000 |