Panels › Clinical Toxicology › Product code DKZ · Class 2
Enzyme Immunoassay, Amphetamine
Regulation 862.3100
0510(k)s in 12 months (225 all time)
0recalls in 12 months (24 all time)
20recalls that name a 510(k)
Top companies in DKZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 1997 | K972891 | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION Roche Diagnostic Systems, Inc. | DKZ |
| Aug 12, 1997 | K972032 | VISUALINE II METHAMPHETIMINE Sun Biomedical Laboratories, Inc. | DKZ |
| Jun 26, 1997 | K970395 | QUIKSTRIP ONE STEP METHAMPHETAMINE Drial Consultants, Inc. | DKZ |
| May 30, 1997 | K971218 | QUIKSTRIP ONE STEP AMPHETAMINE TEST Drial Consultants, Inc. | DKZ |
| May 14, 1997 | K971109 | QUIKPAC II ONE STEP AMPHETAMINE TEST Drial Consultants, Inc. | DKZ |
| May 13, 1997 | K970724 | QUICKPAC II ONE STEP METHAMPHETAMINE TEST Drial Consultants, Inc. | DKZ |
| Apr 8, 1997 | K970265 | ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST Drial Consultants, Inc. | DKZ |
| Oct 7, 1996 | K962411 | ONTRAK TESTCUP AMPHETAMINES Roche Diagnostic Systems, Inc. | DKZ |
| Feb 16, 1996 | K955934 | TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 Biosite Incorporated | DKZ |
| Feb 15, 1996 | K955935 | TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS Biosite Incorporated | DKZ |
| Oct 6, 1995 | K953115 | AXSYM AMPHETAMINE/METHAMPHETAMINE II Abbott Laboratories | DKZ |
| Jul 14, 1995 | K935573 | AMPHETAMINES MICRO-PLATE EIA Solarcare Technologies Corp,Inc. | DKZ |
| May 8, 1995 | K951154 | CEDIA DAU AMPHETAMINES ASSAY Microgenics Corp. | DKZ |
| May 1, 1995 | K942836 | FINGERPRINT-DOA Fingerprint Bioteck, Inc. | DKZ |
| Apr 13, 1995 | K945610 | ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP Princeton BioMeditech Corp. | DKZ |
| Mar 30, 1995 | K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DKZ |
| Feb 22, 1995 | K943439 | ABUSIGN DOA4 Princeton BioMeditech Corp. | DKZ |
| Feb 22, 1995 | K935352 | EMIT(R) IIC AMPHETAMINE ASSAY Syva Co. | DKZ |
| Dec 7, 1994 | K944604 | CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS Beckman-Diagnostic Systems Group | DKZ |
| Oct 21, 1994 | K943993 | CEDIA DAU AMPHETAMINES ASSAY Microgenics Corp. | DKZ |
| Sep 16, 1994 | K935052 | MICROLINE SCREEN FOR AMPHETAMINE Drug Screening Systems, Inc. | DKZ |
| Jul 20, 1994 | K941372 | CEDIA DAU AMPHETAMINES ASSAY Microgenics Corp. | DKZ |
| Jan 25, 1994 | K935042 | ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT Roche Diagnostic Systems, Inc. | DKZ |
| Jan 13, 1994 | K934891 | AMPHETAMINES EIA ASSAY MODIFICATION Diagnostic Reagents, Inc. | DKZ |
| Dec 7, 1993 | K932304 | MICRO EIA FOR AMPHETAMINE METABOLITES Microdiagnostics, Inc. | DKZ |
| Nov 22, 1993 | K934693 | AMPHETAMINE TEST SYSTEM U.S. Drug Testing, Inc. | DKZ |
| Sep 15, 1993 | K933052 | ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED Roche Diagnostic Systems, Inc. | DKZ |
| Jul 20, 1993 | K931498 | SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY Solarcare Technologies Corp,Inc. | DKZ |
| Apr 16, 1993 | K930690 | STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA Solarcare Technologies Corp,Inc. | DKZ |
| Jan 22, 1993 | K924476 | THE TRIAGE II Biosite Incorporated | DKZ |
| May 26, 1992 | K921998 | ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED Roche Diagnostic Systems, Inc. | DKZ |
| May 4, 1992 | K921554 | AMPHETAMINES EIA TEST Diagnostic Reagents, Inc. | DKZ |
| Mar 19, 1992 | K920018 | ACCUSCREEN ASSAY Jk Research | DKZ |
| Feb 27, 1992 | K920507 | EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY Syva Co. | DKZ |
| Nov 7, 1991 | K913738 | IL TEST(TM) AMPHETAMINE Instrumentation Laboratory CO | DKZ |
| Oct 11, 1991 | K914146 | BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE Biosite Incorporated | DKZ |
| Jul 26, 1991 | K912758 | ABUSCREEN ONLINE FOR AMPHETAMINES Roche Diagnostic Systems, Inc. | DKZ |
| Apr 3, 1991 | K910658 | ABUSCREEN ONTRAK FOR METHAMPHETAMINE Roche Diagnostic Systems, Inc. | DKZ |
| Apr 3, 1991 | K910278 | ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) Roche Diagnostic Systems, Inc. | DKZ |
| Mar 21, 1991 | K910739 | TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) V-Tech, Inc. | DKZ |
| Mar 19, 1991 | K910738 | TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) V-Tech, Inc. | DKZ |
| Mar 11, 1991 | K910756 | ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) Roche Diagnostic Systems, Inc. | DKZ |
| Jan 15, 1991 | K905700 | EZ-SCREEN: AMPHETAMINES Environmental Diagnostics, Inc. | DKZ |
| Dec 20, 1990 | K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT Immunotech Corp. | DKZ |
| Nov 28, 1990 | K904115 | HYCOR ACCUPINCH METHAMPHETAMINE TEST Hycor Biomedical, Inc. | DKZ |
| Nov 21, 1990 | K904451 | MILENIA (TM) METHAMPHETAMINE Diagnostic Products Corp. | DKZ |
| Sep 27, 1990 | K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY Technicon Instruments Corp. | DKZ |
| Sep 7, 1990 | K902979 | MILENIA (TM) AMPHETAMINE Diagnostic Products Corp. | DKZ |
| Apr 20, 1990 | K900995 | EMIT D.A.U. AMPHETAMINE CLASS ASSAY Syva Co. | DKZ |
| Mar 9, 1990 | K900143 | ABUSCREEN FP FOR METHAMPHETAMINE Roche Diagnostic Systems, Inc. | DKZ |
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