Panels › Clinical Toxicology › Product code DJZ · Class 1
Devices, Breath Trapping, Alcohol
Regulation 862.3050
0510(k)s in 12 months (28 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in DJZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Khn Solutions, LLC | 4 | 0 |
| Akers Biosciences, Inc. | 3 | 0 |
| Sentech Korea Corp. | 3 | 0 |
| ACON Laboratories, Inc. | 1 | 1 |
| Q3 Innovations, LLC | 2 | 0 |
| Alcopro, Inc. | 1 | 0 |
| Alcotest Quebec | 1 | 0 |
| The Ashley Collection, Inc. | 1 | 0 |
| Canada, Inc. | 1 | 0 |
| Connectables, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2016 | K160613 | Soberlink Cellular Device and Sober Sky Web Portal Soberlink Healthcare, LLC | DJZ |
| Apr 29, 2013 | K123470 | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE Pas Systems International, Inc. | DJZ |
| Nov 21, 2011 | K110614 | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM Seju Engineering Co., Ltd., KR | DJZ |
| Apr 6, 2011 | K102225 | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST Alcopro, Inc. | DJZ |
| Jan 12, 2011 | K102338 | BREATHSCN PRO Akers Biosciences, Inc. | DJZ |
| Aug 4, 2010 | K100879 | CONTRALCO Contralco | DJZ |
| Jan 28, 2010 | K093143 | MISSION BREATH ALCOHOL DETECTOR ACON Laboratories, Inc. | DJZ |
| Nov 18, 2009 | K091714 | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 Skyfine Inc. Limited, TW | DJZ |
| Jul 23, 2009 | K090766 | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER Lifeloc Technologies, Inc. | DJZ |
| Apr 1, 2009 | K082080 | ALCO TUBE PLUS Alcotest Quebec | DJZ |
| Mar 24, 2009 | K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 Khn Solutions, LLC | DJZ |
| Mar 19, 2009 | K083801 | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 Khn Solutions, LLC | DJZ |
| Dec 19, 2008 | K082086 | KEY RING ALCOHOL BREATHALYZER The Ashley Collection, Inc. | DJZ |
| Dec 19, 2008 | K081855 | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) Canada, Inc. | DJZ |
| Jul 25, 2008 | K080848 | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR Q3 Innovations, LLC | DJZ |
| Mar 11, 2008 | K063443 | DRAEGER ALCOTEST 6510 Drager Safety | DJZ |
| Jan 7, 2008 | K072953 | REDLINE ALCOHOL BREATH TESTER Redline Products (Pty) , Ltd., ZA | DJZ |
| Sep 14, 2007 | K071067 | BACTRACK LCD ALCOHOL DETECTOR Khn Solutions, LLC | DJZ |
| Apr 9, 2007 | K062545 | RMI LCD ALCOHOL DETECTOR Resource Management International, LLC | DJZ |
| Dec 18, 2006 | K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS Akers Biosciences, Inc. | DJZ |
| Oct 30, 2006 | K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 Sentech Korea Corp., KR | DJZ |
| May 11, 2006 | K060343 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 Sentech Korea Corp. | DJZ |
| Apr 28, 2006 | K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS Akers Biosciences, Inc. | DJZ |
| Feb 23, 2006 | K052448 | POCKET BREATHALYZER. CONNECTABLES Connectables, LLC | DJZ |
| Jan 20, 2006 | K053332 | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 Sentech Korea Corp. | DJZ |
| Dec 9, 2005 | K052804 | BREATHKEY MODEL G10/BREATHKEY MODEL G30X Omega Point Systems, LLC | DJZ |
| Feb 9, 2005 | K043188 | ALCOHAWK PRECISION Q3 Innovations, LLC | DJZ |
| Aug 11, 2004 | K041334 | ALCOMATE, MODEL CA2000 Khn Solutions, LLC | DJZ |
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