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510(k) K011306

Device
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
Applicant
SYVA CO., DADE BEHRING, INC.
510(k) number
K011306
Product code
JXM  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-16
Date received
2001-04-30
Regulation
862.3170
Classification name
Enzyme Immunoassay, Benzodiazepine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA ARREDONO
Address
3403 Yerba Buena Rd. San Jose CA US 95135 95135

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243498Alinity c Benzodiazepines Reagent KitMicrogenics Corporation2024-12-11
K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics2022-12-23
K190968CEDIA Benzodiazepine AssayMicrogenics Corporation2019-12-09
K173963DRI Benzodiazepine AssayMicrogenics Corporation2018-02-21
K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation2017-09-15
K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC2017-08-02
K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC2016-05-23
K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation2016-01-05
K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC2015-08-13
K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC2015-05-13
K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSChemtron Biotech, Inc.2012-11-29
K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDChemtron Biotech, Inc.2011-09-14
K092274RANDOX BENZODIAZEPINE ASSAYRandox Laboratories, Ltd.2010-10-15
K062285VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVOrtho-Clinical Diagnostics, Inc.2006-12-22
K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000Acro Biotech, LLC2006-07-28

Legacy Summary#

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FDA Review#

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