FDA 510(k) Applications for Medical Device Product Code "DKZ"
(Enzyme Immunoassay, Amphetamine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K020313 | ACON LABORATORIES CO. | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE | 05/08/2002 |
| K041822 | ACON LABORATORIES, INC. | ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE | 09/16/2004 |
| K011673 | ACON LABORATORIES, INC. | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE | 07/31/2001 |
| K041685 | ACON LABORATORIES, INC. | ACON MULTI-CLIN DRUG SCREEN TEST DEVICE | 08/30/2004 |
| K031759 | ACON LABORATORIES, INC. | ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD | 08/04/2003 |
| K041743 | ACON LABORATORIES, INC. | ACON TRI-FECT DRUG SCREEN TEST DEVICE | 09/09/2004 |
| K053032 | ACRO BIOTECH LLC. | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 | 02/09/2006 |
| K023712 | ADVANTAGE DIAGNOSTICS CORP | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST | 01/31/2003 |
| K122809 | ADVIN BIOTECH | ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP | 06/17/2013 |
| K173303 | Alfa Scientific Designs, Inc | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | 02/23/2018 |
| K994395 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST | 08/07/2000 |
| K994399 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST | 08/04/2000 |
| K131645 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | 10/07/2013 |
| K022564 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST | 08/30/2002 |
| K152122 | ALFA SCIENTIFIC DESIGNS, INC. | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | 06/24/2016 |
| K023104 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN AMPHETAMINE TEST | 12/16/2002 |
| K063379 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 | 12/11/2006 |
| K053175 | AMEDITECH, INC. | AMEDITECH DRUGSMARTCUP | 12/08/2005 |
| K040092 | AMEDITECH, INC. | AMEDITECH IMMU TEST DRUG SCREEN PANEL | 03/08/2004 |
| K012484 | AMEDITECH, INC. | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE | 11/30/2001 |
| K113046 | AMEDITECH, INC. | AMEDITECH IMMUTEST MILTI-DRUG SCREEN | 11/10/2011 |
| K050186 | AMEDITECH, INC. | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III | 03/04/2005 |
| K981705 | AMERICAN BIO MEDICA CORP. | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME | 08/27/1998 |
| K983770 | AMERICAN BIO MEDICA CORP. | 'RAPID DRUG SCREEN' 9-PANEL | 12/31/1998 |
| K021114 | AMERICAN BIO MEDICA CORP. | 'RAPIDTEC' 5A MULTIPLE DIP TEST | 07/23/2002 |
| K992033 | AMERICAN BIO MEDICA CORP. | MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL | 06/30/1999 |
| K002447 | AMERICAN BIO MEDICA CORP. | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL | 11/16/2000 |
| K012159 | AMERICAN BIO MEDICA CORP. | RAPID DRUG SCREEN | 07/25/2001 |
| K984525 | AMERICAN BIO MEDICA CORP. | RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST | 02/26/1999 |
| K041696 | AMERICAN BIO MEDICA CORP. | RAPID READER | 07/12/2005 |
| K053359 | AMERICAN BIO MEDICA CORP. | RAPIDTOX | 05/25/2006 |
| K981504 | AMERITEK, INC. | DBEST AMPHETAMINES TEST KIT | 08/06/1998 |
| K990681 | AMERITEK, INC. | DBSET MULTIDRUG SCREEN TEST KIT | 07/15/1999 |
| K061005 | APPLIED DNA TECHNOLOGIES, INC. | ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS | 10/04/2006 |
| K973726 | APPLIED TECHNOLOGY VENTURES, L.L.C. | FINGERPRINT DRUG SCREENING DEVICE | 11/06/1997 |
| K153465 | Assure Tech (Hangzhou) Co., Ltd. | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | 03/31/2016 |
| K191099 | Atlas Medical | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | 10/03/2019 |
| K000606 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS AMPHETAMINE REAGENT | 05/05/2000 |
| K141748 | BIOPHOR DIAGNOSTICS, INC. | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET | 05/20/2015 |
| K014247 | BIOSITE INCORPORATED | TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 | 06/03/2002 |
| K955934 | BIOSITE INCORPORATED | TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 | 02/16/1996 |
| K973784 | BIOSITE INCORPORATED | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS | 12/03/1997 |
| K955935 | BIOSITE INCORPORATED | TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS | 02/15/1996 |
| K012745 | BIOSITE INCORPORATED | TRIAGE TOX DRUG SCREEN, CATALOG #94000 | 01/10/2002 |
| K040203 | BRANAN MEDICAL CORP. | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 | 03/25/2004 |
| K004034 | BRANAN MEDICAL CORP. | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 | 03/08/2001 |
| K002266 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST | 11/22/2000 |
| K142580 | CHEMTRON BIOTECH, INC. | Chemtrue Multi-Panel DOA DIP Card Tests | 12/01/2014 |
| K102203 | CHEMTRON BIOTECH, INC. | CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS | 01/20/2011 |
| K121339 | CHEMTRON BIOTECH, INC. | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS | 05/17/2012 |
| K131110 | CO-INNOVATION BIOTECH CO., LTD. | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | 01/15/2014 |
| K142800 | Co-Innovation Biotech Co., Ltd. | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | 12/11/2014 |
| K152590 | CORETESTS, INC | ACCU NEWS Drug Screening Test Card/Urine Cup | 04/15/2016 |
| K053337 | DADE BEHRING, INC. | DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 | 05/19/2006 |
| K043028 | DADE BEHRING, INC. | EMIT II PLUS ECSTASY ASSAY | 01/07/2005 |
| K031004 | DADE BEHRING, INC. | SYVA EMIT II PLUS AMPHETAMINES ASSAY | 06/06/2003 |
| K000460 | DADE BEHRING, INC. | URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A | 04/14/2000 |
| K040133 | DADE BEHRING, INC. | URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE | 04/08/2004 |
| K992632 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 | 01/27/2000 |
| K970265 | DRIAL CONSULTANTS, INC. | ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST | 04/08/1997 |
| K970724 | DRIAL CONSULTANTS, INC. | QUICKPAC II ONE STEP METHAMPHETAMINE TEST | 05/13/1997 |
| K971109 | DRIAL CONSULTANTS, INC. | QUIKPAC II ONE STEP AMPHETAMINE TEST | 05/14/1997 |
| K971218 | DRIAL CONSULTANTS, INC. | QUIKSTRIP ONE STEP AMPHETAMINE TEST | 05/30/1997 |
| K970395 | DRIAL CONSULTANTS, INC. | QUIKSTRIP ONE STEP METHAMPHETAMINE | 06/26/1997 |
| K000400 | DRUG DETECTION DEVICES, LTD. | SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST | 04/18/2000 |
| K052115 | FIRST CHECK DIAGNOSTICS LLC | FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY | 12/29/2005 |
| K130082 | GENPRIME, INC | GENPRIME DRUGS OF ABUSE READER SYSTEM | 12/20/2013 |
| K141532 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE | 07/14/2014 |
| K122961 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) | 12/21/2012 |
| K121987 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST | 08/01/2012 |
| K111560 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST | 07/15/2011 |
| K122904 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; | 11/15/2012 |
| K133968 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO MULTI-DRUG URINE TEST CUP, PANEL | 02/25/2014 |
| K182738 | Hangzhou AllTest Biotech Co., Ltd | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick | 03/27/2019 |
| K161251 | Hangzhou Clongene Biotech Co., Ltd | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | 08/30/2016 |
| K152269 | HEALGEN SCIENTIFIC LLC | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) | 09/09/2015 |
| K051579 | Immunalysis Corporation | IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS | 10/21/2005 |
| K143500 | Immunalysis Corporation | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | 02/06/2015 |
| K060810 | IND DIAGNOSTIC INC. | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | 08/07/2006 |
| K061718 | INNOVACON, INC. | INNOVACON SPECTRUM II TEST CARD | 11/13/2006 |
| K020395 | Lin-Zhi International, Inc. | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | 06/04/2002 |
| K033094 | Lin-Zhi International, Inc. | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) | 12/19/2003 |
| K063024 | Lin-Zhi International, Inc. | LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS | 10/30/2006 |
| K102210 | Lin-Zhi International, Inc. | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS | 12/28/2010 |
| K131653 | Lin-Zhi International, Inc. | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | 02/04/2014 |
| K080635 | MEDTOX DIAGNOSTICS, INC. | MEDTOXSCAN | 02/13/2009 |
| K050394 | MEDTOX DIAGNOSTICS, INC. | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS | 10/25/2005 |
| K010564 | MEDTOX DIAGNOSTICS, INC. | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO | 04/05/2001 |
| K011952 | MICRODIAGNOSTICS, INC. | DRUGS OF ABUSE MULTI-TEST STRIP | 10/25/2001 |
| K974611 | MICRODIAGNOSTICS, INC. | MICRO-STRIP FOR AMPHETAMINE METABOLITES | 03/20/1998 |
| K994380 | MICROGENICS CORP. | CEDIA DAU AMPHASSURE ASSAY | 05/02/2000 |
| K012110 | MICROGENICS CORP. | DRI ECSTASY ENZYME IMMUNOASSAY | 08/27/2001 |
| K101745 | MICROGENICS CORP. | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | 04/08/2011 |
| K093114 | MICROGENICS CORP. | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY | 05/12/2010 |
| K080057 | NOVX SYSTEMS INC. | IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL | 10/31/2008 |
| K142855 | Omega Laboratories, Inc. | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | 07/28/2015 |
| K992918 | ORASURE TECHNOLOGIES, INC. | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I | 04/03/2000 |
| K972989 | ORASURE TECHNOLOGIES, INC. | STC METHAMPHETAMINE MICRO-PLATE EIA | 01/28/1998 |
| K062077 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS | 11/22/2006 |
| K011609 | PAN PROBE BIOTECH, INC. | LIVESURE AMPHETAMINE SCREEN TEST | 06/08/2001 |
| K994237 | PHAMATECH | AT HOME DRUG TEST, MODEL 9063 | 12/30/1999 |
| K010645 | PHAMATECH | AT HOME DRUG TEST, MODEL 9063 T | 03/30/2001 |
| K001397 | PHAMATECH | QUICKSCREEN PRO DRUG CUP, MODEL 9195X | 05/26/2000 |
| K980865 | PHAMATECH | QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 | 04/01/1998 |
| K131069 | PHAMATECH INC. | QUICKSCREEN AMPHETINE 500 TEST | 05/14/2014 |
| K181945 | Phamatech Inc. | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | 10/18/2018 |
| K121065 | POLYMED THERAPEUTICS, INC | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE | 05/24/2013 |
| K001225 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. | 05/17/2000 |
| K130811 | PSYCHEMEDICS CORP. | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE | 05/02/2013 |
| K051161 | QUEST DIAGNOSTICS, INC. | QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) | 11/22/2005 |
| K182719 | Quidel Cardiovascular Inc. | Quidel Triage TOX Drug Screen, 94600; Quidel Triage« MeterPro | 06/19/2019 |
| K200363 | Quidel Cardiovascular Inc. | Quidel Triage« TOX Drug Screen, 94600 | 03/11/2020 |
| K040350 | RANDOX LABORATORIES, LTD. | RANDOX AMPHETAMINE CLASS ASSAY | 05/12/2004 |
| K092275 | RANDOX LABORATORIES, LTD. | RANDOX ECSTASY (MDMA) ASSAY | 03/01/2011 |
| K033566 | RAPID DIAGNOSTICS, INC. | MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 | 05/17/2004 |
| K003809 | RAPID DIAGNOSTICS, INC. | RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS | 04/20/2001 |
| K972891 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION | 10/01/1997 |
| K983699 | ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | 12/11/1998 |
| K962411 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP AMPHETAMINES | 10/07/1996 |
| K973075 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON | 10/09/1997 |
| K110446 | Roche Diagnostics | ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID | 05/03/2011 |
| K083764 | ROCHE DIAGNOSTICS CORP. | AMPHETAMINES II | 02/03/2010 |
| K093664 | ROCHE DIAGNOSTICS CORP. | AMPHETAMINES II ASSAY | 07/28/2010 |
| K003865 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA AMPHETAMINES | 02/28/2001 |
| K012396 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCARD 9 | 11/05/2001 |
| K001421 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP 501, MODEL 3016633 | 07/12/2000 |
| K001417 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP 502, MODEL 3016641 | 06/29/2000 |
| K990399 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 | 04/15/1999 |
| K990337 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP-5 M2K | 02/23/1999 |
| K990418 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP-ER M2K | 04/13/1999 |
| K180879 | SHANGHAI VENTURE BIO-TECH CO., LTD. | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | 12/14/2018 |
| K021006 | STARPLEX SCIENTIFIC, INC. | STARTOX DRUG OF ABUSE SCREENING TEST | 06/10/2002 |
| K011499 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE AMPHETAMINE DIPSTRIP ASSAY | 07/17/2001 |
| K010177 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY | 05/17/2001 |
| K972032 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE II METHAMPHETIMINE | 08/12/1997 |
| K990325 | SYNTRON BIORESEARCH, INC. | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | 06/24/1999 |
| K012257 | SYVA CO. | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 | 08/03/2001 |
| K981197 | TCPI, INC. | ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST | 06/16/1998 |
| K061617 | Tianjin New Bay Bioresearch Co., Ltd. | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST | 11/22/2006 |
| K052882 | Tianjin New Bay Bioresearch Co., Ltd. | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE | 02/15/2006 |
| K071489 | Tianjin New Bay Bioresearch Co., Ltd. | HOMECHECK MULTIPLE DRUG CUP TEST | 03/28/2008 |
| K152908 | UCP BIOSCIENCES, INC | UCP COMPACT DRUG TESTS | 05/03/2016 |
| K151213 | UCP BIOSCIENCES, INC | UCP Drug Test Mini Cups | 08/21/2015 |
| K123863 | UCP BIOSCIENCES, INC. | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | 01/09/2013 |
| K131811 | UCP BIOSCIENCES, INC. | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | 07/19/2013 |
| K122419 | UCP BIOSCIENCES, INC. | UCP HOME DRUG SCREENING TEST CUPS | 11/30/2012 |
| K130463 | UCP BIOSCIENCES, INC. | UCP HOME DRUG SCREENING TEST; CARDS, CUPS | 05/15/2013 |
| K091588 | UCP BIOSCIENCES, INC. | UCP HOME DRUG SCREENING TESTS | 09/04/2009 |
| K132812 | UCP BIOSCIENCES, INC. | UCP MULTI-DRUG TEST KEY CUPS | 03/06/2014 |
| K050540 | UCP BIOSCIENCES, INC. | UCP RAPID DRUG SCREENING TESTS | 04/29/2005 |
| K051235 | VARIAN INC | ON TRAK TESTCARD | 06/08/2005 |
| K033902 | VARIAN INC | ONTRAK TESTCUP II AND ONSITE CUPKIT | 01/20/2004 |
| K033659 | VARIAN INC | VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK | 01/06/2004 |
| K032575 | W.H.P.M., INC. | FIRST SIGN DRUG OF ABUSE SCREENING TEST | 05/19/2004 |
| K020869 | WORLDWIDE MEDICAL CORP. | FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) | 06/11/2002 |
| K051966 | WORLDWIDE MEDICAL LLC | FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY | 09/07/2005 |
| K231137 | Xenta Biomedical Science Co., Ltd. | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | 05/19/2023 |
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