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510(k) K023184

Device
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Applicant
Bayer Diagnostics Corp.
510(k) number
K023184
Product code
DIC
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-18
Date received
2002-09-24
Regulation
862.3040
Classification name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K121247ALCO-SCREENChematics, Inc.2013-03-22
K121256ALCO-SCREEN 02Chematics, Inc.2012-09-12
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K092273RANDOX ETHANOL ASSAYRandox Laboratories, Ltd.2010-11-01
K093879MISSION SALIVA ALCOHOL TEST STRIPACON Laboratories, Inc.2010-08-06
K071811ETOH FLEX REAGENT CARTRIDGE (DF22)Dade Behring, Inc.2007-08-24
K070853DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022Dade Behring, Inc.2007-06-13
K061792DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRIDade Behring, Inc.2006-07-18
K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc.2003-10-03
K010960EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229Syva Co., Dade Behring, Inc.2001-04-26
K001286ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10Diagnostic Chemicals , Ltd.2000-06-20
K993920ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17Diagnostic Chemicals , Ltd.2000-01-18