DJZ · Class I · 21 CFR 862.3050

FDA Product Code DJZ: Devices, Breath Trapping, Alcohol

Leading manufacturers include Khn Solutions, LLC, Sentech Korea Corp. and Akers Biosciences, Inc..

28
Total
28
Cleared
144d
Avg days
2004
Since

FDA 510(k) Cleared Devices, Breath Trapping, Alcohol Devices (Product Code DJZ)

28 devices
1–24 of 28
Cleared Jul 14, 2016
Soberlink Cellular Device and Sober Sky Web Portal
K160613
Soberlink Healthcare, LLC
Toxicology · 133d
Cleared Apr 29, 2013
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470
Pas Systems International, Inc.
Toxicology · 167d
Cleared Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614
Seju Engineering Co., Ltd.
Chemistry · 263d
Cleared Apr 06, 2011
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
K102225
Alcopro, Inc.
Toxicology · 240d
Cleared Jan 12, 2011
BREATHSCN PRO
K102338
Akers Biosciences, Inc.
Toxicology · 147d
Cleared Aug 04, 2010
CONTRALCO
K100879
Contralco
Toxicology · 127d
Cleared Jan 28, 2010
MISSION BREATH ALCOHOL DETECTOR
K093143
ACON Laboratories, Inc.
Toxicology · 115d
Cleared Nov 18, 2009
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714
Skyfine Inc. Limited
Toxicology · 161d
Cleared Jul 23, 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766
Lifeloc Technologies, Inc.
Chemistry · 122d
Cleared Apr 01, 2009
ALCO TUBE PLUS
K082080
Alcotest Quebec
Toxicology · 252d
Cleared Mar 24, 2009
BACTRACK SELECT BREATHALYZER, MODEL S80
K090067
Khn Solutions, LLC
Toxicology · 74d
Cleared Mar 19, 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801
Khn Solutions, LLC
Toxicology · 87d
Cleared Dec 19, 2008
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855
Canada, Inc.
Toxicology · 172d
Cleared Dec 19, 2008
KEY RING ALCOHOL BREATHALYZER
K082086
The Ashley Collection, Inc.
Toxicology · 149d
Cleared Jul 25, 2008
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848
Q3 Innovations, LLC
Chemistry · 121d
Cleared Mar 11, 2008
DRAEGER ALCOTEST 6510
K063443
Drager Safety
Chemistry · 483d
Cleared Jan 07, 2008
REDLINE ALCOHOL BREATH TESTER
K072953
Redline Products (Pty) , Ltd.
Toxicology · 81d
Cleared Sep 14, 2007
BACTRACK LCD ALCOHOL DETECTOR
K071067
Khn Solutions, LLC
Chemistry · 151d
Cleared Apr 09, 2007
RMI LCD ALCOHOL DETECTOR
K062545
Resource Management International, LLC
Toxicology · 222d
Cleared Dec 18, 2006
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
K062971
Akers Biosciences, Inc.
Toxicology · 80d
Cleared Oct 30, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922
Sentech Korea Corp.
Chemistry · 115d
Cleared May 11, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K060343
Sentech Korea Corp.
Toxicology · 90d
Cleared Apr 28, 2006
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
K060761
Akers Biosciences, Inc.
Toxicology · 38d
Cleared Feb 23, 2006
POCKET BREATHALYZER. CONNECTABLES
K052448
Connectables, LLC
Toxicology · 169d

About Product Code DJZ - Regulatory Context