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DJZ — Devices, Breath Trapping, Alcohol Class I

FDA Device Classification

Classification Details

Product Code
DJZ
Device Class
Class I
Regulation Number
862.3050
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160613soberlink healthcareSoberlink Cellular Device and Sober Sky Web PortalJuly 14, 2016
K123470pas systems internationalPAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITEApril 29, 2013
K110614seju engineering coPAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEMNovember 21, 2011
K102225alcoproALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTApril 6, 2011
K102338akers biosciencesBREATHSCN PROJanuary 12, 2011
K100879contralcoCONTRALCOAugust 4, 2010
K093143acon laboratoriesMISSION BREATH ALCOHOL DETECTORJanuary 28, 2010
K091714skyfine inc. limitedALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579November 18, 2009
K090766lifeloc technologiesLIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTERJuly 23, 2009
K082080alcotest quebecALCO TUBE PLUSApril 1, 2009
K090067khn solutionsBACTRACK SELECT BREATHALYZER, MODEL S80March 24, 2009
K083801khn solutionsBACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70March 19, 2009
K082086ashley collectionKEY RING ALCOHOL BREATHALYZERDecember 19, 2008
K081855canadaIMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)December 19, 2008
K080848q3 innovationsALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTORJuly 25, 2008
K063443drager safetyDRAEGER ALCOTEST 6510March 11, 2008
K072953redline products (pty)REDLINE ALCOHOL BREATH TESTERJanuary 7, 2008
K071067khn solutionsBACTRACK LCD ALCOHOL DETECTORSeptember 14, 2007
K062545resource management internationalRMI LCD ALCOHOL DETECTORApril 9, 2007
K062971akers biosciencesBREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMSDecember 18, 2006