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 30, 2024 | K240670 | DRI Ecstasy Plus Assay Microgenics Corporation | DKZ |
| Dec 13, 2023 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Mu Hangzhou AllTest Biotech Co., Ltd., CN | DKZ |
| May 19, 2023 | K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Xenta Biomedical Science Co., Ltd., CN | DKZ |
| Mar 11, 2020 | K200363 | Quidel Triage® TOX Drug Screen, 94600 Quidel Cardiovascular, Inc. | DKZ |
| Oct 3, 2019 | K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel Atlas Medical, JO | DKZ |
| Jun 19, 2019 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro Quidel Cardiovascular, Inc. | DKZ |
| Mar 27, 2019 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single Hangzhou AllTest Biotech Co., Ltd., CN | DKZ |
| Dec 14, 2018 | K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO Shanghai Venture Bio-Tech Co., Ltd., CN | DKZ |
| Oct 18, 2018 | K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z Phamatech, Inc. | DKZ |
| Feb 23, 2018 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simpl Alfa Scientific Designs, Inc. | DKZ |
| Aug 30, 2016 | K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests Hangzhou Clongene Biotech Co., Ltd., CN | DKZ |
| Jun 24, 2016 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) Alfa Scientific Designs, Inc. | DKZ |
| May 3, 2016 | K152908 | UCP COMPACT DRUG TESTS Ucp Biosciences, Inc. | DKZ |
| Apr 15, 2016 | K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup Coretests, Inc. | DKZ |
| Mar 31, 2016 | K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card Assure Tech. (Hangzhou) Co, Ltd., CN | DKZ |
| Sep 9, 2015 | K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healge Healgen Scientific,, LLC | DKZ |
| Aug 21, 2015 | K151213 | UCP Drug Test Mini Cups Ucp Biosciences, Inc. | DKZ |
| Jul 28, 2015 | K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) Omega Laboratories, Inc. | DKZ |
| May 20, 2015 | K141748 | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHET Biophor Diagnostics, Inc. | DKZ |
| Feb 6, 2015 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urin Immunalysis Corporation | DKZ |
| Dec 11, 2014 | K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard Co-Innovation Biotech Co., Ltd., CN | DKZ |
| Dec 1, 2014 | K142580 | Chemtrue Multi-Panel DOA DIP Card Tests Chemtron Biotech, Inc. | DKZ |
| Jul 14, 2014 | K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| May 14, 2014 | K131069 | QUICKSCREEN AMPHETINE 500 TEST Phamatech, Inc. | DKZ |
| Mar 6, 2014 | K132812 | UCP MULTI-DRUG TEST KEY CUPS Ucp Biosciences, Inc. | DKZ |
| Feb 25, 2014 | K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Feb 4, 2014 | K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc. | DKZ |
| Jan 15, 2014 | K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD Co-Innovation Biotech Co., Ltd., CN | DKZ |
| Dec 20, 2013 | K130082 | GENPRIME DRUGS OF ABUSE READER SYSTEM Genprime, Inc. | DKZ |
| Oct 7, 2013 | K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) Alfa Scientific Designs, Inc. | DKZ |
| Jul 19, 2013 | K131811 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS Ucp Biosciences, Inc. | DKZ |
| Jun 17, 2013 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup Advin Biotech | DKZ |
| May 24, 2013 | K121065 | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE Polymed Therapeutics, Inc. | DKZ |
| May 15, 2013 | K130463 | UCP HOME DRUG SCREENING TEST; CARDS, CUPS Ucp Biosciences, Inc. | DKZ |
| May 2, 2013 | K130811 | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE Psychemedics Corp. | DKZ |
| Jan 9, 2013 | K123863 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS Ucp Biosciences, Inc. | DKZ |
| Dec 21, 2012 | K122961 | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Nov 30, 2012 | K122419 | UCP HOME DRUG SCREENING TEST CUPS Ucp Biosciences, Inc. | DKZ |
| Nov 15, 2012 | K122904 | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Aug 1, 2012 | K121987 | WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| May 17, 2012 | K121339 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS Chemtron Biotech, Inc. | DKZ |
| Nov 10, 2011 | K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN Ameditech, Inc. | DKZ |
| Jul 15, 2011 | K111560 | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| May 3, 2011 | K110446 | ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID Roche Diagnostics | DKZ |
| Apr 8, 2011 | K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY Microgenics Corp. | DKZ |
| Mar 1, 2011 | K092275 | RANDOX ECSTASY (MDMA) ASSAY Randox Laboratories, Ltd., GB | DKZ |
| Jan 20, 2011 | K102203 | CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS Chemtron Biotech, Inc. | DKZ |
| Dec 28, 2010 | K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS Lin-Zhi International, Inc. | DKZ |
| Jul 28, 2010 | K093664 | AMPHETAMINES II ASSAY Roche Diagnostics Corp. | DKZ |
| May 12, 2010 | K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY Microgenics Corp. | DKZ |
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