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DKZ

225 FDA 510(k) clearances · Product code

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RecordFirmDate
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K020313)Acon Laboratories Co.2002-05-08
TRIAGE TOX DRUG SCREEN, CATALOG #94000 (K012745)Biosite Incorporated2002-01-10
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (K012484)Ameditech, Inc.2001-11-30
ONTRAK TESTCARD 9 (K012396)Roche Diagnostics Corp.2001-11-05
DRUGS OF ABUSE MULTI-TEST STRIP (K011952)Microdiagnostics, Inc.2001-10-25
DRI ECSTASY ENZYME IMMUNOASSAY (K012110)Microgenics Corp.2001-08-27
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (K012257)Syva Co.2001-08-03
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE (K011673)ACON Laboratories, Inc.2001-07-31
RAPID DRUG SCREEN (K012159)American Bio Medica Corp.2001-07-25
VISUALINE AMPHETAMINE DIPSTRIP ASSAY (K011499)Sun Biomedical Laboratories, Inc.2001-07-17
LIVESURE AMPHETAMINE SCREEN TEST (K011609)Pan Probe Biotech, Inc.2001-06-08
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY (K010177)Sun Biomedical Laboratories, Inc.2001-05-17
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS (K003809)Rapid Diagnostics, Inc.2001-04-20
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO (K010564)Medtox Diagnostics, Inc.2001-04-05
AT HOME DRUG TEST, MODEL 9063 T (K010645)Phamatech2001-03-30
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 (K004034)Branan Medical Corp.2001-03-08
COBAS INTEGRA AMPHETAMINES (K003865)Roche Diagnostics Corp.2001-02-28
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST (K002266)Branan Medical Corporation2000-11-22
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL (K002447)American Bio Medica Corp.2000-11-16
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST (K994395)Alfa Scientific Designs, Inc.2000-08-07
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST (K994399)Alfa Scientific Designs, Inc.2000-08-04
ONTRAK TESTCUP 501, MODEL 3016633 (K001421)Roche Diagnostics Corp.2000-07-12
ONTRAK TESTCUP 502, MODEL 3016641 (K001417)Roche Diagnostics Corp.2000-06-29
QUICKSCREEN PRO DRUG CUP, MODEL 9195X (K001397)Phamatech2000-05-26
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. (K001225)Princeton BioMeditech Corp.2000-05-17
SYNCHRON SYSTEMS AMPHETAMINE REAGENT (K000606)Beckman Coulter, Inc.2000-05-05
CEDIA DAU AMPHASSURE ASSAY (K994380)Microgenics Corp.2000-05-02
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST (K000400)Drug Detection Devices, Ltd.2000-04-18
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A (K000460)Dade Behring, Inc.2000-04-14
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I (K992918)OraSure Technologies, Inc.2000-04-03
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 (K992632)Diagnostic Products Corp.2000-01-27
AT HOME DRUG TEST, MODEL 9063 (K994237)Phamatech1999-12-30
DBSET MULTIDRUG SCREEN TEST KIT (K990681)Ameritek, Inc.1999-07-15
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL (K992033)American Bio Medica Corp.1999-06-30
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE (K990325)Syntron Bioresearch, Inc.1999-06-24
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 (K990399)Roche Diagnostics Corp.1999-04-15
ONTRAK TESTCUP-ER M2K (K990418)Roche Diagnostics Corp.1999-04-13
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST (K984525)American Bio Medica Corp.1999-02-26
ONTRAK TESTCUP-5 M2K (K990337)Roche Diagnostics Corp.1999-02-23
'RAPID DRUG SCREEN' 9-PANEL (K983770)American Bio Medica Corp.1998-12-31
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (K983699)Roche Diagnostic Systems, Inc.1998-12-11
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME (K981705)American Bio Medica Corp.1998-08-27
DBEST AMPHETAMINES TEST KIT (K981504)Ameritek, Inc.1998-08-06
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (K981197)Tcpi, Inc.1998-06-16
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 (K980865)Phamatech1998-04-01
MICRO-STRIP FOR AMPHETAMINE METABOLITES (K974611)Microdiagnostics, Inc.1998-03-20
STC METHAMPHETAMINE MICRO-PLATE EIA (K972989)OraSure Technologies, Inc.1998-01-28
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS (K973784)Biosite Incorporated1997-12-03
FINGERPRINT DRUG SCREENING DEVICE (K973726)Applied Technology Ventures, LLC1997-11-06
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON (K973075)Roche Diagnostic Systems, Inc.1997-10-09
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION (K972891)Roche Diagnostic Systems, Inc.1997-10-01
VISUALINE II METHAMPHETIMINE (K972032)Sun Biomedical Laboratories, Inc.1997-08-12
QUIKSTRIP ONE STEP METHAMPHETAMINE (K970395)Drial Consultants, Inc.1997-06-26
QUIKSTRIP ONE STEP AMPHETAMINE TEST (K971218)Drial Consultants, Inc.1997-05-30
QUIKPAC II ONE STEP AMPHETAMINE TEST (K971109)Drial Consultants, Inc.1997-05-14
QUICKPAC II ONE STEP METHAMPHETAMINE TEST (K970724)Drial Consultants, Inc.1997-05-13
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST (K970265)Drial Consultants, Inc.1997-04-08
ONTRAK TESTCUP AMPHETAMINES (K962411)Roche Diagnostic Systems, Inc.1996-10-07
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 (K955934)Biosite Incorporated1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS (K955935)Biosite Incorporated1996-02-15
AXSYM AMPHETAMINE/METHAMPHETAMINE II (K953115)Abbott Laboratories1995-10-06
AMPHETAMINES MICRO-PLATE EIA (K935573)Solarcare Technologies Corp,Inc.1995-07-14
CEDIA DAU AMPHETAMINES ASSAY (K951154)Microgenics Corp.1995-05-08
FINGERPRINT-DOA (K942836)Fingerprint Bioteck, Inc.1995-05-01
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP (K945610)Princeton BioMeditech Corp.1995-04-13
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950135)E.I. Dupont DE Nemours & Co., Inc.1995-03-30
ABUSIGN DOA4 (K943439)Princeton BioMeditech Corp.1995-02-22
EMIT(R) IIC AMPHETAMINE ASSAY (K935352)Syva Co.1995-02-22
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (K944604)Beckman-Diagnostic Systems Group1994-12-07
CEDIA DAU AMPHETAMINES ASSAY (K943993)Microgenics Corp.1994-10-21
MICROLINE SCREEN FOR AMPHETAMINE (K935052)Drug Screening Systems, Inc.1994-09-16
CEDIA DAU AMPHETAMINES ASSAY (K941372)Microgenics Corp.1994-07-20
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT (K935042)Roche Diagnostic Systems, Inc.1994-01-25
AMPHETAMINES EIA ASSAY MODIFICATION (K934891)Diagnostic Reagents, Inc.1994-01-13
MICRO EIA FOR AMPHETAMINE METABOLITES (K932304)Microdiagnostics, Inc.1993-12-07
AMPHETAMINE TEST SYSTEM (K934693)U.S. Drug Testing, Inc.1993-11-22
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED (K933052)Roche Diagnostic Systems, Inc.1993-09-15
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY (K931498)Solarcare Technologies Corp,Inc.1993-07-20
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA (K930690)Solarcare Technologies Corp,Inc.1993-04-16
THE TRIAGE II (K924476)Biosite Incorporated1993-01-22
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED (K921998)Roche Diagnostic Systems, Inc.1992-05-26
AMPHETAMINES EIA TEST (K921554)Diagnostic Reagents, Inc.1992-05-04
ACCUSCREEN ASSAY (K920018)Jk Research1992-03-19
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY (K920507)Syva Co.1992-02-27
IL TEST(TM) AMPHETAMINE (K913738)Instrumentation Laboratory CO1991-11-07
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE (K914146)Biosite Incorporated1991-10-11
ABUSCREEN ONLINE FOR AMPHETAMINES (K912758)Roche Diagnostic Systems, Inc.1991-07-26
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) (K910278)Roche Diagnostic Systems, Inc.1991-04-03
ABUSCREEN ONTRAK FOR METHAMPHETAMINE (K910658)Roche Diagnostic Systems, Inc.1991-04-03
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (K910739)V-Tech, Inc.1991-03-21
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (K910738)V-Tech, Inc.1991-03-19
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) (K910756)Roche Diagnostic Systems, Inc.1991-03-11
EZ-SCREEN: AMPHETAMINES (K905700)Environmental Diagnostics, Inc.1991-01-15
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT (K903993)Immunotech Corp.1990-12-20
HYCOR ACCUPINCH METHAMPHETAMINE TEST (K904115)Hycor Biomedical, Inc.1990-11-28
MILENIA (TM) METHAMPHETAMINE (K904451)Diagnostic Products Corp.1990-11-21
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (K903824)Technicon Instruments Corp.1990-09-27
MILENIA (TM) AMPHETAMINE (K902979)Diagnostic Products Corp.1990-09-07
EMIT D.A.U. AMPHETAMINE CLASS ASSAY (K900995)Syva Co.1990-04-20
ABUSCREEN FP FOR METHAMPHETAMINE (K900143)Roche Diagnostic Systems, Inc.1990-03-09
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