FDA 510(k) Applications for Medical Device Product Code "DJZ"
(Devices, Breath Trapping, Alcohol)

FDA 510(k) Number Applicant Device Name Decision Date
K093143 ACON LABORATORIES, INC. MISSION BREATH ALCOHOL DETECTOR 01/28/2010
K062971 Akers Biosciences, Inc. BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS 12/18/2006
K060761 Akers Biosciences, Inc. BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS 04/28/2006
K102338 Akers Biosciences, Inc. BREATHSCN PRO 01/12/2011
K102225 ALCOPRO, INC. ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST 04/06/2011
K082080 ALCOTEST QUEBEC ALCO TUBE PLUS 04/01/2009
K081855 CANADA, INC. IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) 12/19/2008
K052448 CONNECTABLES, LLC POCKET BREATHALYZER. CONNECTABLES 02/23/2006
K100879 CONTRALCO CONTRALCO 08/04/2010
K063443 DRAGER SAFETY DRAEGER ALCOTEST 6510 03/11/2008
K041334 KHN SOLUTIONS, LLC ALCOMATE, MODEL CA2000 08/11/2004
K071067 KHN SOLUTIONS, LLC BACTRACK LCD ALCOHOL DETECTOR 09/14/2007
K090067 KHN SOLUTIONS, LLC BACTRACK SELECT BREATHALYZER, MODEL S80 03/24/2009
K083801 KHN SOLUTIONS, LLC BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 03/19/2009
K090766 LIFELOC TECHNOLOGIES, INC. LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER 07/23/2009
K052804 OMEGAPOINT SYSTEMS, LLC BREATHKEY MODEL G10/BREATHKEY MODEL G30X 12/09/2005
K123470 PAS SYSTEMS INTERNATIONAL, INC. PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE 04/29/2013
K080848 Q3 INNOVATIONS, LLC ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR 07/25/2008
K043188 Q3 INNOVATIONS, LLC ALCOHAWK PRECISION 02/09/2005
K072953 REDLINE PRODUCTS (PTY) LTD. REDLINE ALCOHOL BREATH TESTER 01/07/2008
K062545 RESOURCE MANAGEMENT INTERNATIONAL, LLC RMI LCD ALCOHOL DETECTOR 04/09/2007
K110614 SEJU ENGINEERING CO., LTD. PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM 11/21/2011
K053332 SENTECH KOREA CORP. BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 01/20/2006
K061922 SENTECH KOREA CORP. BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 10/30/2006
K060343 SENTECH KOREA CORP. BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 05/11/2006
K091714 SKYFINE INC. LIMITED ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 11/18/2009
K160613 SOBERLINK HEALTHCARE LLC Soberlink Cellular Device and Sober Sky Web Portal 07/14/2016
K082086 THE ASHLEY COLLECTION, INC. KEY RING ALCOHOL BREATHALYZER 12/19/2008


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