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 |
|---|---|---|---|
| Feb 3, 2010 | K083764 | AMPHETAMINES II Roche Diagnostics Corp. | DKZ |
| Sep 4, 2009 | K091588 | UCP HOME DRUG SCREENING TESTS Ucp Biosciences, Inc. | DKZ |
| Feb 13, 2009 | K080635 | MEDTOXSCAN Medtox Diagnostics, Inc. | DKZ |
| Oct 31, 2008 | K080057 | IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL Novx Systems, Inc. | DKZ |
| Mar 28, 2008 | K071489 | HOMECHECK MULTIPLE DRUG CUP TEST Tianjin New Bay Bioresearch Co., Ltd. | DKZ |
| Dec 11, 2006 | K063379 | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 Amedica Biotech, Inc. | DKZ |
| Nov 22, 2006 | K062077 | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc. | DKZ |
| Nov 22, 2006 | K061617 | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST Tianjin New Bay Bioresearch Co., Ltd. | DKZ |
| Nov 13, 2006 | K061718 | INNOVACON SPECTRUM II TEST CARD Innovacon, Inc. | DKZ |
| Oct 30, 2006 | K063024 | LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DKZ |
| Oct 4, 2006 | K061005 | ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS Applied Dna Technologies, Inc. | DKZ |
| Aug 7, 2006 | K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC Ind Diagnostic, Inc., CA | DKZ |
| May 25, 2006 | K053359 | RAPIDTOX American Bio Medica Corp. | DKZ |
| May 19, 2006 | K053337 | DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 Dade Behring, Inc. | DKZ |
| Feb 15, 2006 | K052882 | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE Tianjin New Bay Bioresearch Co., Ltd. | DKZ |
| Feb 9, 2006 | K053032 | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 Acro Biotech, LLC | DKZ |
| Dec 29, 2005 | K052115 | FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY First Check Diagnostics, LLC | DKZ |
| Dec 8, 2005 | K053175 | AMEDITECH DRUGSMARTCUP Ameditech, Inc. | DKZ |
| Nov 22, 2005 | K051161 | QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) Quest Diagnostics, Inc. | DKZ |
| Oct 25, 2005 | K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS Medtox Diagnostics, Inc. | DKZ |
| Oct 21, 2005 | K051579 | IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation | DKZ |
| Sep 7, 2005 | K051966 | FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY Worldwide Medical, LLC | DKZ |
| Jul 12, 2005 | K041696 | RAPID READER American Bio Medica Corp. | DKZ |
| Jun 8, 2005 | K051235 | ON TRAK TESTCARD Varian, Inc. | DKZ |
| Apr 29, 2005 | K050540 | UCP RAPID DRUG SCREENING TESTS Ucp Biosciences, Inc. | DKZ |
| Mar 4, 2005 | K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III Ameditech, Inc. | DKZ |
| Jan 7, 2005 | K043028 | EMIT II PLUS ECSTASY ASSAY Dade Behring, Inc. | DKZ |
| Sep 16, 2004 | K041822 | ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE ACON Laboratories, Inc. | DKZ |
| Sep 9, 2004 | K041743 | ACON TRI-FECT DRUG SCREEN TEST DEVICE ACON Laboratories, Inc. | DKZ |
| Aug 30, 2004 | K041685 | ACON MULTI-CLIN DRUG SCREEN TEST DEVICE ACON Laboratories, Inc. | DKZ |
| Jun 3, 2004 | K033743 | COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT Cozart Bioscience , Ltd., GB | DKZ |
| May 19, 2004 | K032575 | FIRST SIGN DRUG OF ABUSE SCREENING TEST W.H.P.M., Inc. | DKZ |
| May 17, 2004 | K033566 | MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 Rapid Diagnostics, Inc. | DKZ |
| May 12, 2004 | K040350 | RANDOX AMPHETAMINE CLASS ASSAY Randox Laboratories, Ltd., GB | DKZ |
| Apr 8, 2004 | K040133 | URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE Dade Behring, Inc. | DKZ |
| Mar 25, 2004 | K040203 | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 Branan Medical Corp. | DKZ |
| Mar 8, 2004 | K040092 | AMEDITECH IMMU TEST DRUG SCREEN PANEL Ameditech, Inc. | DKZ |
| Jan 20, 2004 | K033902 | ONTRAK TESTCUP II AND ONSITE CUPKIT Varian, Inc. | DKZ |
| Jan 6, 2004 | K033659 | VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK Varian, Inc. | DKZ |
| Dec 19, 2003 | K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) Lin-Zhi International, Inc. | DKZ |
| Aug 4, 2003 | K031759 | ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD ACON Laboratories, Inc. | DKZ |
| Jun 6, 2003 | K031004 | SYVA EMIT II PLUS AMPHETAMINES ASSAY Dade Behring, Inc. | DKZ |
| Jan 31, 2003 | K023712 | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST Advantage Diagnostics Corp. | DKZ |
| Dec 16, 2002 | K023104 | AMEDICA DRUG SCREEN AMPHETAMINE TEST Amedica Biotech, Inc. | DKZ |
| Aug 30, 2002 | K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST Alfa Scientific Designs, Inc. | DKZ |
| Jul 23, 2002 | K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST American Bio Medica Corp. | DKZ |
| Jun 11, 2002 | K020869 | FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) Worldwide Medical Corp. | DKZ |
| Jun 10, 2002 | K021006 | STARTOX DRUG OF ABUSE SCREENING TEST Starplex Scientific, Inc. | DKZ |
| Jun 4, 2002 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) Lin-Zhi International, Inc. | DKZ |
| Jun 3, 2002 | K014247 | TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 Biosite Incorporated | DKZ |
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