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510(k) K250609

Device
Sober Self-Test
Applicant
Sober Ip, LLC
510(k) number
K250609
Product code
DIC
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-15
Date received
2025-02-28
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
Timothy Downey
Address
27694 Franklin Rd. Southfield MI US 48034 48034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DIC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation2018-10-31
K121247ALCO-SCREENChematics, Inc.2013-03-22
K121256ALCO-SCREEN 02Chematics, Inc.2012-09-12
K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.2011-11-15
K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics2011-10-04
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
K023184ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBayer Diagnostics Corp.2002-11-18
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