ClearanceBrief
Panels › Clinical Toxicology › Product code JXM · Class 2

Enzyme Immunoassay, Benzodiazepine

Regulation 862.3170

0510(k)s in 12 months (90 all time)
0recalls in 12 months (81 all time)
80recalls that name a 510(k)
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Top companies in JXM

Company510(k)sRecalls
Ameditech Inc079
Syva Co.130
Abbott Laboratories80
Microgenics Corp.70
Roche Diagnostic Systems, Inc.70
Healgen Scientific,, LLC40
OraSure Technologies, Inc.22
Princeton BioMeditech Corp.40
Beckman Coulter, Inc.30
E.I. Dupont DE Nemours & Co., Inc.30
Decided510(k)Device and applicantCode
Dec 11, 2024K243498Alinity c Benzodiazepines Reagent Kit
Microgenics Corporation
JXM
Dec 23, 2022K221765ONLINE DAT Benzodiazepines II
Roche Diagnostics
JXM
Dec 9, 2019K190968CEDIA Benzodiazepine Assay
Microgenics Corporation
JXM
Feb 21, 2018K173963DRI Benzodiazepine Assay
Microgenics Corporation
JXM
Sep 15, 2017K163590Psychemedics Microplate EIA for Benzodiazepines in Hair
Psychemedics Corporation
JXM
Aug 2, 2017K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific,, LLC
JXM
May 23, 2016K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific,, LLC
JXM
Jan 5, 2016K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Immunalysis Corporation
JXM
Aug 13, 2015K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific,, LLC
JXM
May 13, 2015K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific,, LLC
JXM
Nov 29, 2012K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
Chemtron Biotech, Inc.
JXM
Sep 14, 2011K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
Chemtron Biotech, Inc.
JXM
Oct 15, 2010K092274RANDOX BENZODIAZEPINE ASSAY
Randox Laboratories, Ltd., GB
JXM
Dec 22, 2006K062285VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Ortho-Clinical Diagnostics, Inc.
JXM
Jul 28, 2006K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
Acro Biotech, LLC
JXM
Jun 13, 2005K051307SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
Beckman Coulter, Inc.
JXM
May 17, 2005K050179RANDOX BENZODIAZEPINE CLASS ASSAY
Randox Laboratories, Ltd., GB
JXM
Mar 28, 2005K043556SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
Beckman Coulter, Inc.
JXM
Feb 7, 2005K043327ONLINE DAT BENZODIAZEPINES PLUS
Roche Diagnostics Corp.
JXM
Dec 29, 2004K043167PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
Phamatech, Inc.
JXM
Sep 5, 2003K032365BENZODIAZEPINE ENZYME IMMUNOASSAY
Lin-Zhi International, Inc.
JXM
Nov 7, 2002K023048MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Beckman Coulter, Inc.
JXM
Apr 17, 2002K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
OraSure Technologies, Inc.
JXM
Mar 13, 2002K013143BENZODIAZEPINES
Abbott Laboratories
JXM
Sep 17, 2001K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
ACON Laboratories, Inc.
JXM
Jul 20, 2001K012131LIVESURE BENZODIAZEPINES SCREEN TESTS
Pan Probe Biotech, Inc.
JXM
May 29, 2001K003881INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
Alfa Scientific Designs, Inc.
JXM
May 29, 2001K003879INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
Alfa Scientific Designs, Inc.
JXM
May 16, 2001K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
Syva Co., Dade Behring, Inc.
JXM
Nov 27, 2000K002342BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
Branan Medical Corporation
JXM
Apr 17, 2000K000458URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
Dade Behring, Inc.
JXM
Apr 7, 2000K000449SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
Drug Detection Devices, Ltd.
JXM
Apr 3, 2000K992720RAPIDONE- BENZODIAZEPINE TEST
American Bio Medica Corp.
JXM
Jan 27, 2000K993985SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
Syva Co.
JXM
Jun 22, 1999K991443ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
Roche Diagnostics Corp.
JXM
Apr 15, 1999K991079ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
Princeton BioMeditech Corp.
JXM
Feb 11, 1999K983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
Roche Diagnostic Systems, Inc.
JXM
Nov 18, 1998K983174ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
Roche Diagnostic Systems, Inc.
JXM
Nov 12, 1998K982831AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
OraSure Technologies, Inc.
JXM
Jun 3, 1998K981687QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
Phamatech
JXM
Apr 29, 1998K980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
Tcpi, Inc.
JXM
Feb 25, 1998K973269QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
Drial Consultants, Inc.
JXM
Feb 24, 1998K973326QUIKPAC II ONE STEP BENZODIAZEPINE TEST
Drial Consultants, Inc.
JXM
Dec 11, 1997K974181ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
Princeton BioMeditech Corp.
JXM
Dec 10, 1996K962734CEDIA DAU BENZODIAZEPINE ASSAY
Boehringer Mannheim Corp.
JXM
Aug 30, 1996K962672ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
Princeton BioMeditech Corp.
JXM
Jun 12, 1996K961325ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
Princeton BioMeditech Corp.
JXM
May 20, 1996K960708BENZODIAZEPINE SERUM TOX EIA TEST
Diagnostic Reagents, Inc.
JXM
Nov 27, 1995K954626CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
Microgenics Corp.
JXM
Oct 5, 1995K953105VISUALINE II BENZODIAZEPINES
Sun Biomedical Laboratories, Inc.
JXM

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