ClearanceBrief
Panels › Clinical Toxicology › Product code DJC · Class 2

Thin Layer Chromatography, Methamphetamine

Regulation 862.3610

1510(k)s in 12 months (31 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in DJC

Company510(k)sRecalls
Alfa Scientific Designs, Inc.30
Acro Biotech, LLC20
Bd Becton Dickinson Vacutainer Systems Preanalytic20
Branan Medical Corporation20
Cordis Corp.20
Medtox Diagnostics, Inc.20
Premier Biotech, Inc.20
Amedica Biotech, Inc.10
American Bio Medica Corp.10
Assure Tech. (Hangzhou) Co, Ltd.10
Decided510(k)Device and applicantCode
Mar 16, 2026K253705Healgen® Accurate Oral Fluid Drug Test
Healgen Scientific,, LLC
DJC
Mar 18, 2025K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Hangzhou Laihe Biotech Co., Ltd., CN
DJC
Dec 17, 2018K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTU
Shanghai Venture Bio-Tech Co., Ltd., CN
DJC
Sep 20, 2018K181305OralTox Oral fluid Drug Test
Premier Biotech, Inc.
DJC
Feb 2, 2018K171403OralTox Oral Fluid Drug Test
Premier Biotech, Inc.
DJC
Jul 6, 2016K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (St
Assure Tech. (Hangzhou) Co, Ltd., CN
DJC
Sep 27, 2013K132630WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
Guangzhou Wondfo Biotech Co., Ltd.
DJC
Oct 9, 2008K080347UNISCAN -DOA SYSTEM
Taiwan Unison Biotech, Inc., TW
DJC
Aug 7, 2006K060355ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
Acro Biotech, LLC
DJC
Jun 9, 2006K060896MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
Varian, Inc.
DJC
Jun 6, 2006K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
Acro Biotech, LLC
DJC
Oct 17, 2003K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
Amedica Biotech, Inc.
DJC
Feb 27, 2003K022388STARTOX DRUG OF ABUSE SCREENING TEST (4)
Starplex Scientific, Inc.
DJC
Nov 13, 2002K022501INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
Alfa Scientific Designs, Inc.
DJC
Jul 30, 2002K022141VERDICT-II
Medtox Diagnostics, Inc.
DJC
Jan 24, 2002K011185PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
Psychemedics Corp.
DJC
Nov 26, 2001K013180RAPIDONE-ECSTASY TEST
American Bio Medica Corp.
DJC
Jun 1, 2001K010226VERDICT -II METHAMPHETAMINE
Medtox Diagnostics, Inc.
DJC
Nov 27, 2000K002265BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
Branan Medical Corporation
DJC
Nov 22, 2000K002587BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
Branan Medical Corporation
DJC
Aug 14, 2000K994406INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
Alfa Scientific Designs, Inc.
DJC
Aug 4, 2000K994400INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
Alfa Scientific Designs, Inc.
DJC
Jul 10, 2000K001356ONTRAK TESTCUP PRO-5, MODEL 1986678
Roche Diagnostics Corp.
DJC
Oct 6, 1999K993100REDI-SCREEN
Redwood Biotech, Inc.
DJC
Oct 24, 1978K781156DIALYSIS SYS., PDS 400 & RO 400
Physio-Control Corp.
DJC
Oct 17, 1978K781153KIDNEY, ARTIFICIAL
Bd Becton Dickinson Vacutainer Systems Preanalytic
DJC
Sep 7, 1978K781140CUTTER RESIFLEX FOLEY CATHETERS
Cutler Laboratories, Inc.
DJC
Aug 31, 1978K781238KIDNEY, ARTIFICIAL, C-DAK 1.5
Cordis Corp.
DJC
Aug 31, 1978K781237KIDNEY, ARTIFICIAL, C-DAK 2.0
Cordis Corp.
DJC
Aug 18, 1978K781110BANDAGE, COMPRESSION, FISTULAID
Medical Device Laboratories
DJC
Aug 17, 1978K781331A-V FISTULA NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
DJC

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