FDA 510(k) Applications for Medical Device Product Code "DJC"
(Thin Layer Chromatography, Metamphetamine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K060355 | ACRO BIOTECH LLC. | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | 08/07/2006 |
| K053033 | ACRO BIOTECH LLC. | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | 06/06/2006 |
| K022501 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | 11/13/2002 |
| K994400 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST | 08/04/2000 |
| K994406 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | 08/14/2000 |
| K031497 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST | 10/17/2003 |
| K013180 | AMERICAN BIO MEDICA CORP. | RAPIDONE-ECSTASY TEST | 11/26/2001 |
| K161044 | ASSURE TECH (HANGZHOU) CO., LTD. | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | 07/06/2016 |
| K002587 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | 11/22/2000 |
| K002265 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | 11/27/2000 |
| K132630 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) | 09/27/2013 |
| K010226 | MEDTOX DIAGNOSTICS, INC. | VERDICT -II METHAMPHETAMINE | 06/01/2001 |
| K022141 | MEDTOX DIAGNOSTICS, INC. | VERDICT-II | 07/30/2002 |
| K171403 | Premier Biotech Inc | OralTox Oral Fluid Drug Test | 02/02/2018 |
| K181305 | Premier Biotech, Inc. | OralTox Oral fluid Drug Test | 09/20/2018 |
| K011185 | PSYCHEMEDICS CORP. | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | 01/24/2002 |
| K993100 | REDWOOD BIOTECH, INC. | REDI-SCREEN | 10/06/1999 |
| K001356 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP PRO-5, MODEL 1986678 | 07/10/2000 |
| K180878 | Shanghai Venture Bio-Tech CO., Ltd. | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Tes | 12/17/2018 |
| K022388 | STARPLEX SCIENTIFIC, INC. | STARTOX DRUG OF ABUSE SCREENING TEST (4) | 02/27/2003 |
| K080347 | TAIWAN UNISON BIOTECH, INC. | UNISCAN -DOA SYSTEM | 10/09/2008 |
| K060896 | VARIAN INC | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | 06/09/2006 |
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