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JXM — Enzyme Immunoassay, Benzodiazepine Class II

FDA Device Classification

Classification Details

Product Code
JXM
Device Class
Class II
Regulation Number
862.3170
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243498microgenics corporationAlinity c Benzodiazepines Reagent KitDecember 11, 2024
K221765roche diagnosticsONLINE DAT Benzodiazepines IIDecember 23, 2022
K190968microgenics corporationCEDIA Benzodiazepine AssayDecember 9, 2019
K173963microgenics corporationDRI Benzodiazepine AssayFebruary 21, 2018
K163590psychemedics corporationPsychemedics Microplate EIA for Benzodiazepines in HairSeptember 15, 2017
K163704healgen scientificHealgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardAugust 2, 2017
K153597healgen scientificHealgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardMay 23, 2016
K151771immunalysis corporationImmunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalJanuary 5, 2016
K151642healgen scientificHeagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardAugust 13, 2015
K150356healgen scientificHealgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardMay 13, 2015
K123080chemtron biotechCHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSNovember 29, 2012
K111322chemtron biotechCHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDSeptember 14, 2011
K092274randox laboratoriesRANDOX BENZODIAZEPINE ASSAYOctober 15, 2010
K062285ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DDecember 22, 2006
K060354acro biotechACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000July 28, 2006
K051307beckman coulterSYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENTJune 13, 2005
K050179randox laboratoriesRANDOX BENZODIAZEPINE CLASS ASSAYMay 17, 2005
K043556beckman coulterSYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENTMarch 28, 2005
K043327roche diagnosticsONLINE DAT BENZODIAZEPINES PLUSFebruary 7, 2005
K043167phamatechPHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND December 29, 2004