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
K781331 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC A-V FISTULA NEEDLE 08/17/1978
K781153 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC KIDNEY, ARTIFICIAL 10/17/1978
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
K781238 CORDIS CORP. KIDNEY, ARTIFICIAL, C-DAK 1.5 08/31/1978
K781237 CORDIS CORP. KIDNEY, ARTIFICIAL, C-DAK 2.0 08/31/1978
K781140 CUTLER LABORATORIES, INC. CUTTER RESIFLEX FOLEY CATHETERS 09/07/1978
K132630 Guangzhou Wondfo Biotech Co., Ltd. WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) 09/27/2013
K781110 MEDICAL DEVICE LABORATORIES BANDAGE, COMPRESSION, FISTULAID 08/18/1978
K010226 MEDTOX DIAGNOSTICS, INC. VERDICT -II METHAMPHETAMINE 06/01/2001
K022141 MEDTOX DIAGNOSTICS, INC. VERDICT-II 07/30/2002
K781156 PHYSIO-CONTROL CORP. DIALYSIS SYS., PDS 400 & RO 400 10/24/1978
K171403 Premier Biotech Inc OralTox Oral Fluid Drug Test 02/02/2018
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
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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