FDA 510(k) Applications for Medical Device Product Code "JXM"
(Enzyme Immunoassay, Benzodiazipine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013143 | ABBOTT LABORATORIES | BENZODIAZEPINES | 03/13/2002 |
| K012300 | ACON LABORATORIES, INC. | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | 09/17/2001 |
| K060354 | ACRO BIOTECH LLC. | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | 07/28/2006 |
| K003881 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST | 05/29/2001 |
| K003879 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) | 05/29/2001 |
| K992720 | AMERICAN BIO MEDICA CORP. | RAPIDONE- BENZODIAZEPINE TEST | 04/03/2000 |
| K023048 | BECKMAN COULTER, INC. | MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT | 11/07/2002 |
| K051307 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT | 06/13/2005 |
| K043556 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT | 03/28/2005 |
| K962734 | BOEHRINGER MANNHEIM CORP. | CEDIA DAU BENZODIAZEPINE ASSAY | 12/10/1996 |
| K002342 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST | 11/27/2000 |
| K111322 | CHEMTRON BIOTECH, INC. | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | 09/14/2011 |
| K123080 | CHEMTRON BIOTECH, INC. | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | 11/29/2012 |
| K000458 | DADE BEHRING, INC. | URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A | 04/17/2000 |
| K960708 | DIAGNOSTIC REAGENTS, INC. | BENZODIAZEPINE SERUM TOX EIA TEST | 05/20/1996 |
| K973326 | DRIAL CONSULTANTS, INC. | QUIKPAC II ONE STEP BENZODIAZEPINE TEST | 02/24/1998 |
| K973269 | DRIAL CONSULTANTS, INC. | QUIKSTRIP ONE STEP BENZODIAZEPINE TEST | 02/25/1998 |
| K000449 | DRUG DETECTION DEVICES, LTD. | SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST | 04/07/2000 |
| K151642 | HEALGEN SCIENTIFIC LLC | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | 08/13/2015 |
| K153597 | HEALGEN SCIENTIFIC LLC | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | 05/23/2016 |
| K150356 | HEALGEN SCIENTIFIC LLC | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | 05/13/2015 |
| K163704 | HEALGEN SCIENTIFIC LLC | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | 08/02/2017 |
| K151771 | IMMUNALYSIS CORPORATION | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 01/05/2016 |
| K032365 | Lin-Zhi International, Inc. | BENZODIAZEPINE ENZYME IMMUNOASSAY | 09/05/2003 |
| K190968 | Microgenics Corporation | CEDIA Benzodiazepine Assay | 12/09/2019 |
| K173963 | Microgenics Corporation | DRI Benzodiazepine Assay | 02/21/2018 |
| K982831 | ORASURE TECHNOLOGIES, INC. | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U | 11/12/1998 |
| K013882 | ORASURE TECHNOLOGIES, INC. | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | 04/17/2002 |
| K062285 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | 12/22/2006 |
| K012131 | PAN PROBE BIOTECH, INC. | LIVESURE BENZODIAZEPINES SCREEN TESTS | 07/20/2001 |
| K981687 | PHAMATECH | QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 | 06/03/1998 |
| K043167 | PHAMATECH INC. | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | 12/29/2004 |
| K962672 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY | 08/30/1996 |
| K991079 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO | 04/15/1999 |
| K974181 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B | 12/11/1997 |
| K961325 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP | 06/12/1996 |
| K163590 | Psychemedics Corporation | Psychemedics Microplate EIA for Benzodiazepines in Hair | 09/15/2017 |
| K092274 | RANDOX LABORATORIES, LTD. | RANDOX BENZODIAZEPINE ASSAY | 10/15/2010 |
| K050179 | RANDOX LABORATORIES, LTD. | RANDOX BENZODIAZEPINE CLASS ASSAY | 05/17/2005 |
| K983702 | ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | 02/11/1999 |
| K983174 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES | 11/18/1998 |
| K221765 | Roche Diagnostics | ONLINE DAT Benzodiazepines II | 12/23/2022 |
| K043327 | ROCHE DIAGNOSTICS CORP. | ONLINE DAT BENZODIAZEPINES PLUS | 02/07/2005 |
| K991443 | ROCHE DIAGNOSTICS CORP. | ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) | 06/22/1999 |
| K993985 | SYVA CO. | SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL | 01/27/2000 |
| K011306 | SYVA CO., DADE BEHRING, INC. | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 | 05/16/2001 |
| K980776 | TCPI, INC. | ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST | 04/29/1998 |
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