FDA 510(k) Applications for Medical Device Product Code "DKZ"
(Enzyme Immunoassay, Amphetamine)

FDA 510(k) Number Applicant Device Name Decision Date
K890692 ABBOTT LABORATORIES ADX AMPHETAMINE/METHAMPHEAMINE 08/25/1989
K953115 ABBOTT LABORATORIES AXSYM AMPHETAMINE/METHAMPHETAMINE II 10/06/1995
K895210 ABBOTT LABORATORIES LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II 09/25/1989
K880013 ABBOTT LABORATORIES REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. 03/01/1988
K874486 ABBOTT LABORATORIES REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA. 11/23/1987
K874770 ABBOTT LABORATORIES TDX (R) AMPHETAMINE CLASS 04/21/1988
K853879 ABBOTT LABORATORIES TDX AMPHETAMINE METHAMPHETAMINE 10/28/1985
K883707 ABBOTT LABORATORIES TDX AMPHETAMINE/METHAMPHETAMINE II 10/20/1988
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
K000606 BECKMAN COULTER, INC. SYNCHRON SYSTEMS AMPHETAMINE REAGENT 05/05/2000
K944604 BECKMAN-DIAGNOSTIC SYSTEMS GROUP CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS 12/07/1994
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
K914146 BIOSITE INCORPORATED BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE 10/11/1991
K924476 BIOSITE INCORPORATED THE TRIAGE II 01/22/1993
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
K760196 COULTER ELECTRONICS, INC. ASSAY, AMPHET. NDC#11711-0127-1 COULTER 08/03/1976
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
K871696 DIAGNOSTIC PRODUCTS CORP. DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5 06/05/1987
K992632 DIAGNOSTIC PRODUCTS CORP. IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 01/27/2000
K873755 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY 10/15/1987
K902979 DIAGNOSTIC PRODUCTS CORP. MILENIA (TM) AMPHETAMINE 09/07/1990
K904451 DIAGNOSTIC PRODUCTS CORP. MILENIA (TM) METHAMPHETAMINE 11/21/1990
K934891 DIAGNOSTIC REAGENTS, INC. AMPHETAMINES EIA ASSAY MODIFICATION 01/13/1994
K921554 DIAGNOSTIC REAGENTS, INC. AMPHETAMINES EIA TEST 05/04/1992
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
K935052 DRUG SCREENING SYSTEMS, INC. MICROLINE SCREEN FOR AMPHETAMINE 09/16/1994
K873622 E.I. DUPONT DE NEMOURS & CO., INC. ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH 10/02/1987
K950135 E.I. DUPONT DE NEMOURS & CO., INC. URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE 03/30/1995
K905700 ENVIRONMENTAL DIAGNOSTICS, INC. EZ-SCREEN: AMPHETAMINES 01/15/1991
K942836 FINGERPRINT BIOTECK, INC. FINGERPRINT-DOA 05/01/1995
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
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
K904115 HYCOR BIOMEDICAL, INC. HYCOR ACCUPINCH METHAMPHETAMINE TEST 11/28/1990
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
K903993 IMMUNOTECH CORP. MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT 12/20/1990
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
K913738 INSTRUMENTATION LABORATORY CO. IL TEST(TM) AMPHETAMINE 11/07/1991
K920018 JK RESEARCH ACCUSCREEN ASSAY 03/19/1992
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
K932304 MICRODIAGNOSTICS, INC. MICRO EIA FOR AMPHETAMINE METABOLITES 12/07/1993
K974611 MICRODIAGNOSTICS, INC. MICRO-STRIP FOR AMPHETAMINE METABOLITES 03/20/1998
K994380 MICROGENICS CORP. CEDIA DAU AMPHASSURE ASSAY 05/02/2000
K941372 MICROGENICS CORP. CEDIA DAU AMPHETAMINES ASSAY 07/20/1994
K943993 MICROGENICS CORP. CEDIA DAU AMPHETAMINES ASSAY 10/21/1994
K951154 MICROGENICS CORP. CEDIA DAU AMPHETAMINES ASSAY 05/08/1995
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
K121065 POLYMED THERAPEUTICS, INC POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE 05/24/2013
K943439 PRINCETON BIOMEDITECH CORP. ABUSIGN DOA4 02/22/1995
K945610 PRINCETON BIOMEDITECH CORP. ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP 04/13/1995
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
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
K890886 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR AMPHETAMINE 03/10/1989
K900143 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR METHAMPHETAMINE 03/09/1990
K912758 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE FOR AMPHETAMINES 07/26/1991
K972891 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION 10/01/1997
K933052 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED 09/15/1993
K910658 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONTRAK FOR METHAMPHETAMINE 04/03/1991
K894465 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE 08/15/1989
K874836 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) EIA AMPHETAMINE 02/16/1988
K910756 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) 03/11/1991
K921998 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED 05/26/1992
K910278 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) 04/03/1991
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
K874273 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR AMPHETAMINE TEST KIT 11/13/1987
K874274 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR AMPHETAMINE TEST KIT 11/13/1987
K935042 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT 01/25/1994
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
K935573 SOLARCARE TECHNOLOGIES CORP,INC. AMPHETAMINES MICRO-PLATE EIA 07/14/1995
K931498 SOLARCARE TECHNOLOGIES CORP,INC. SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY 07/20/1993
K930690 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA 04/16/1993
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
K843458 SYVA CO. EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT 09/20/1984
K760936 SYVA CO. EMIT AMPHETAMINE CONFIRMATION REAGENT 11/19/1976
K842674 SYVA CO. EMIT D.A.U. AMPHETAMINE ASSAY 09/26/1984
K900995 SYVA CO. EMIT D.A.U. AMPHETAMINE CLASS ASSAY 04/20/1990
K884022 SYVA CO. EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE 10/11/1988
K894404 SYVA CO. EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE 08/11/1989
K882589 SYVA CO. EMIT HVA AMPHETAMINE ASSAY 08/02/1988
K920507 SYVA CO. EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY 02/27/1992
K012257 SYVA CO. EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 08/03/2001
K935352 SYVA CO. EMIT(R) IIC AMPHETAMINE ASSAY 02/22/1995
K802623 SYVA CO. EMIT-STM AMPHETAMINE ASSAY 11/12/1980
K833579 SYVA CO. MODIF. OF EMIT URINE AMPHETAMINE 01/26/1984
K874080 SYVA CO. REVISED LABELING FOR SYVA AMPHETAMINE ASSAY 10/29/1987
K981197 TCPI, INC. ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST 06/16/1998
K903824 TECHNICON INSTRUMENTS CORP. DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY 09/27/1990
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
K934693 U.S. DRUG TESTING, INC. AMPHETAMINE TEST SYSTEM 11/22/1993
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