FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K013247 |
ABBOTT LABORATORIES |
CANNABINOIDS |
03/13/2002 |
K041221 |
ACCU-STAT DIAGNOSTICS, INC. |
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY |
07/13/2004 |
K040629 |
ACCU-STAT DIAGNOSTICS, INC. |
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE |
05/05/2004 |
K003557 |
ACON LABORATORIES, INC. |
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) |
03/15/2001 |
K050936 |
ACON LABORATORIES, INC. |
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
06/24/2005 |
K050050 |
ACON LABORATORIES, INC. |
ON CALL MULTI-DRUG HOME TEST |
03/11/2005 |
K050878 |
ACON LABORATORIES, INC. |
ON CALL MULTI-DRUG HOME TEST CUP |
06/08/2005 |
K053034 |
ACRO BIOTECH LLC. |
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 |
06/06/2006 |
K010921 |
ADVANTAGE DIAGNOSTICS CORP. |
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST |
06/25/2001 |
K001567 |
ADVANTAGE DIAGNOSTICS CORP. |
ADVANTAGE THC TEST |
06/19/2000 |
K001126 |
ALATEX SCIENTIFIC, INC. |
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST |
08/07/2000 |
K994410 |
ALFA SCIENTIFIC DESIGNS, INC. |
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST |
06/21/2000 |
K022955 |
AMEDICA BIOTECH, INC. |
AMEDICA DRUG SCREEN THC TEST |
11/06/2002 |
K061556 |
AMEDICA BIOTECH, INC. |
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 |
07/21/2006 |
K040464 |
AMEDICA BIOTECH, INC. |
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST |
05/17/2004 |
K080872 |
AMEDICA BIOTECH, INC. |
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ |
08/19/2008 |
K011813 |
AMEDITECH, INC. |
AMEDITECH IMMUTEST DRUG SCREEN THC |
10/22/2001 |
K993961 |
AMERICAN BIO MEDICA CORP. |
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) |
01/24/2000 |
K993796 |
AMERICAN BIO MEDICA CORP. |
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE |
12/21/1999 |
K990818 |
AMERICAN BIO MEDICA CORP. |
RAPIDONE - MARIJUANA TEST |
07/07/1999 |
K983188 |
AMERITEK, INC. |
DBEST TETRAHYDROCANNABINOL TEST KIT |
11/18/1998 |
K080467 |
APPLIED DNA TECHNOLOGIES, INC. |
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, |
11/25/2008 |
K980836 |
APPLIED TECHNOLOGY VENTURES, L.L.C. |
GENIE CUP INTEGRATED SCREENING DEVICE |
06/29/1998 |
K955677 |
BECKMAN INSTRUMENTS, INC. |
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT |
04/03/1996 |
K971841 |
BIONIKE LABORATORIES, INC. |
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST |
06/25/1997 |
K132096 |
BIOPHOR DIAGNOSTICS, INC. |
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR |
10/18/2013 |
K954497 |
BOEHRINGER MANNHEIM CORP. |
FRONTLINE CANNABIS |
03/06/1996 |
K002263 |
BRANAN MEDICAL CORP. |
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST |
11/27/2000 |
K012541 |
BRANAN MEDICAL CORP. |
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET |
09/04/2001 |
K122633 |
BRANAN MEDICAL CORP. |
TOXCUP DRUG SCREEN CUP |
02/07/2013 |
K000461 |
DADE BEHRING, INC. |
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A |
04/06/2000 |
K963916 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE CANNABINOIDS |
04/28/1997 |
K963207 |
DRIAL CONSULTANTS, INC. |
QUICKPAC II ONE STEP MARIJUANA (THC) TEST |
02/20/1997 |
K992949 |
DRUG DETECTION DEVICES, LTD. |
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST |
12/27/1999 |
K012390 |
DRUG FREE ENTERPRISES |
NO STEP ON SITE DEUG TEST CUP |
12/18/2001 |
K963516 |
EDITEK, INC. |
VERDICT THC |
10/30/1996 |
K110182 |
Guangzhou Wondfo Biotech Co., Ltd. |
CANNABINOIDS URINE TEST |
05/20/2011 |
K121557 |
Guangzhou Wondfo Biotech Co., Ltd. |
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST |
07/25/2012 |
K153741 |
HANGZHOU CLONGENE BIOTECH CO., LTD. |
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test |
03/18/2016 |
K223162 |
Healgen Scientific LLC |
Healgen« Accurate Oral Fluid Drug Test, Healgen« Accurate Oral Fluid Drug Test COT |
03/17/2023 |
K140546 |
HEALGEN SCIENTIFIC, LLC |
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST |
06/06/2014 |
K102428 |
HIEN HELEN NGUYEN |
WUNDER TEST |
04/18/2012 |
K151203 |
IMMUNALYSIS CORPORATION |
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set |
06/05/2015 |
K021887 |
Lin-Zhi International, Inc. |
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 |
08/15/2002 |
K110239 |
Lin-Zhi International, Inc. |
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL |
06/23/2011 |
K141320 |
Lin-Zhi International, Inc. |
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls |
05/28/2015 |
K130213 |
LUMIQUICK DIAGNOSTICS, INC. |
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE |
10/18/2013 |
K010138 |
MEDTOX DIAGNOSTICS, INC. |
PROFILE II ER |
02/14/2001 |
K991516 |
MICRODIAGNOSTICS, INC. |
MICRO-STRIP FOR MARIJUANA METABOLITES |
08/05/1999 |
K101744 |
MICROGENICS CORP. |
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY |
04/08/2011 |
K082977 |
MK BIO, INC |
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP |
08/20/2009 |
K050594 |
NANO-DITECH CO. |
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE |
05/15/2005 |
K152643 |
NANTONG EGENS BIOTECH CO., LTD. |
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana |
11/02/2015 |
K122759 |
OMEGA LABORATORIES, INC. |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) |
12/05/2012 |
K002375 |
ORASURE TECHNOLOGIES, INC. |
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I |
01/26/2001 |
K973750 |
ORASURE TECHNOLOGIES, INC. |
STC CANNABINOIDS MICRO-PLATE EIA |
02/13/1998 |
K063164 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
12/28/2006 |
K010001 |
PAN PROBE BIOTECH, INC. |
LIVESURE THC SCREEN TEST |
02/05/2001 |
K994220 |
PHAMATECH |
AT HOME DRUG TEST, MODEL 9078 |
12/30/1999 |
K973122 |
PHAMATECH |
QUICKSCREEN ONE STEP THC SCREENING TEST |
09/25/1997 |
K000131 |
PHAMATECH |
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 |
02/04/2000 |
K142408 |
POLYMED THERAPEUTICS, INC |
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
09/25/2014 |
K014193 |
PRINCETON BIOMEDITECH CORP. |
LIFESIGN DOA 4 (THC/OPI/COC/MET) |
05/23/2002 |
K014066 |
PRINCETON BIOMEDITECH CORP. |
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC |
06/10/2002 |
K111929 |
PSYCHEMEDICS CORP. |
PSYCHEMEDICS CANNABINOIDS EIA |
05/01/2012 |
K040257 |
QUEST DIAGNOSTICS, INC. |
QUEST DIAGNOSTICS HAIRCHECK-DT (THC) |
06/14/2004 |
K092269 |
RANDOX LABORATORIES, LTD. |
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET |
04/08/2011 |
K041142 |
RANDOX LABORATORIES, LTD. |
RANDOX CANNABINOIDS ASSSAY |
11/23/2004 |
K990870 |
REDWOOD BIOTECH, INC. |
REDI-TEST THC |
04/27/1999 |
K981584 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) |
05/28/1998 |
K981585 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) |
05/28/1998 |
K983701 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS |
12/11/1998 |
K030213 |
ROCHE DIAGNOSTICS CORP. |
ONLINE DAT II CANNABINOIDS II |
04/11/2003 |
K994164 |
ROCHE DIAGNOSTICS CORP. |
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 |
04/13/2000 |
K192515 |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 |
10/11/2019 |
K963606 |
SUN BIOMEDICAL LABORATORIES, INC. |
VISUALINE COMBO V (COCAINE/THC) TEST |
10/30/1996 |
K023648 |
SUN BIOMEDICAL LABORATORIES, INC. |
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI |
05/06/2003 |
K963654 |
SYNTRON BIORESEARCH, INC. |
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST |
02/28/1997 |
K993984 |
SYVA CO. |
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL |
01/18/2000 |
K011300 |
SYVA CO., DADE BEHRING, INC. |
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 |
05/17/2001 |
K951853 |
TCPI, INC. |
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) |
08/20/1996 |
K970548 |
TECO DIAGNOSTICS |
ONE STEP MARIJUANA CARD TEST |
07/03/1997 |
K973154 |
UNITED BIOTECH, INC. |
UBI MAGIWEL MARIJUANA METABOLITES |
07/22/1998 |
K993663 |
WORLDWIDE MEDICAL CORP. |
FIRST CHECK HOME DRUG TEST (THC) |
06/23/2000 |
K994139 |
WORLDWIDE MEDICAL CORP. |
FIRST CHECK HOME DRUG TEST PANEL 2 |
06/23/2000 |
K994138 |
WORLDWIDE MEDICAL CORP. |
FIRST CHECK HOME DRUG TEST PANEL 3 |
06/23/2000 |