Product code JXM

Device name: Enzyme Immunoassay, Benzodiazepine
Medical specialty: Clinical Toxicology
Device class: 2
Regulation number: 862.3170
Review panel: TX
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243498	Alinity c Benzodiazepines Reagent Kit	Microgenics Corporation	2024-12-11
K221765	ONLINE DAT Benzodiazepines II	Roche Diagnostics	2022-12-23
K190968	CEDIA Benzodiazepine Assay	Microgenics Corporation	2019-12-09
K173963	DRI Benzodiazepine Assay	Microgenics Corporation	2018-02-21
K163590	Psychemedics Microplate EIA for Benzodiazepines in Hair	Psychemedics Corporation	2017-09-15
K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific,, LLC	2017-08-02
K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific,, LLC	2016-05-23
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	2016-01-05
K151642	Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific,, LLC	2015-08-13
K150356	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	Healgen Scientific,, LLC	2015-05-13
K123080	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS	Chemtron Biotech, Inc.	2012-11-29
K111322	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD	Chemtron Biotech, Inc.	2011-09-14
K092274	RANDOX BENZODIAZEPINE ASSAY	Randox Laboratories, Ltd.	2010-10-15
K062285	VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV	Ortho-Clinical Diagnostics, Inc.	2006-12-22
K060354	ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000	Acro Biotech, LLC	2006-07-28
K051307	SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT	Beckman Coulter, Inc.	2005-06-13
K050179	RANDOX BENZODIAZEPINE CLASS ASSAY	Randox Laboratories, Ltd.	2005-05-17
K043556	SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT	Beckman Coulter, Inc.	2005-03-28
K043327	ONLINE DAT BENZODIAZEPINES PLUS	Roche Diagnostics Corp.	2005-02-07
K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X	Phamatech, Inc.	2004-12-29
K032365	BENZODIAZEPINE ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2003-09-05
K023048	MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT	Beckman Coulter, Inc.	2002-11-07
K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	OraSure Technologies, Inc.	2002-04-17
K013143	BENZODIAZEPINES	Abbott Laboratories	2002-03-13
K012300	ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE	ACON Laboratories, Inc.	2001-09-17
K012131	LIVESURE BENZODIAZEPINES SCREEN TESTS	Pan Probe Biotech, Inc.	2001-07-20
K003879	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)	Alfa Scientific Designs, Inc.	2001-05-29
K003881	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2001-05-29
K011306	EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229	Syva Co., Dade Behring, Inc.	2001-05-16
K002342	BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST	Branan Medical Corporation	2000-11-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10612479255293	McKesson	MCKESSON MEDICAL-SURGICAL INC.	2020-06-18
10612479255323	McKesson	MCKESSON MEDICAL-SURGICAL INC.	2020-06-18
10612479258430	McKesson	MCKESSON MEDICAL-SURGICAL INC.	2020-06-18
M09107RD7065220	QuickProfile™ Drugs of Abuse Panel 6 Test	LUMIQUICK DIAGNOSTICS, INC.	2017-11-15
10694644100140	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100263	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100157	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100164	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100171	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100188	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100195	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100201	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100218	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100225	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100232	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100249	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100256	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100133	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100126	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100119	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100102	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100096	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100089	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100072	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100065	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100058	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100041	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100034	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100027	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23
10694644100010	Rapid TOX	AMERICAN BIO MEDICA CORPORATION	2016-09-23

Product code JXM

Related 510(k) Records#

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