Product code DJZ
- Device name
- Devices, Breath Trapping, Alcohol
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3050
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160613 | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | 2016-07-14 |
| K123470 | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | Pas Systems International, Inc. | 2013-04-29 |
| K110614 | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | Seju Engineering Co., Ltd. | 2011-11-21 |
| K102225 | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | Alcopro, Inc. | 2011-04-06 |
| K102338 | BREATHSCN PRO | Akers Biosciences, Inc. | 2011-01-12 |
| K100879 | CONTRALCO | Contralco | 2010-08-04 |
| K093143 | MISSION BREATH ALCOHOL DETECTOR | ACON Laboratories, Inc. | 2010-01-28 |
| K091714 | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | 2009-11-18 |
| K090766 | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER | Lifeloc Technologies, Inc. | 2009-07-23 |
| K082080 | ALCO TUBE PLUS | Alcotest Quebec | 2009-04-01 |
| K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | Khn Solutions, LLC | 2009-03-24 |
| K083801 | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 | Khn Solutions, LLC | 2009-03-19 |
| K081855 | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) | Canada, Inc. | 2008-12-19 |
| K082086 | KEY RING ALCOHOL BREATHALYZER | The Ashley Collection, Inc. | 2008-12-19 |
| K080848 | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR | Q3 Innovations, LLC | 2008-07-25 |
| K063443 | DRAEGER ALCOTEST 6510 | Drager Safety | 2008-03-11 |
| K072953 | REDLINE ALCOHOL BREATH TESTER | Redline Products (Pty) , Ltd. | 2008-01-07 |
| K071067 | BACTRACK LCD ALCOHOL DETECTOR | Khn Solutions, LLC | 2007-09-14 |
| K062545 | RMI LCD ALCOHOL DETECTOR | Resource Management International, LLC | 2007-04-09 |
| K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS | Akers Biosciences, Inc. | 2006-12-18 |
| K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 | Sentech Korea Corp. | 2006-10-30 |
| K060343 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 | Sentech Korea Corp. | 2006-05-11 |
| K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS | Akers Biosciences, Inc. | 2006-04-28 |
| K052448 | POCKET BREATHALYZER. CONNECTABLES | Connectables, LLC | 2006-02-23 |
| K053332 | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 | Sentech Korea Corp. | 2006-01-20 |
| K052804 | BREATHKEY MODEL G10/BREATHKEY MODEL G30X | Omega Point Systems, LLC | 2005-12-09 |
| K043188 | ALCOHAWK PRECISION | Q3 Innovations, LLC | 2005-02-09 |
| K041334 | ALCOMATE, MODEL CA2000 | Khn Solutions, LLC | 2004-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G354AAB08402 | AlcoBreath Tube | Alcopro Inc. | 2022-09-22 |
| G354AAB15201 | AlcoBreath Tube | Alcopro Inc. | 2022-09-22 |
| G354AAB15402 | AlcoBreath Tube | Alcopro Inc. | 2022-09-22 |
| G354CCP024103 | Checkpoint | Alcopro Inc. | 2022-09-22 |
| G354CCP042001 | Checkpoint | Alcopro Inc. | 2022-09-22 |
| G354CCP044103 | Checkpoint | Alcopro Inc. | 2022-09-22 |
| G354CCP082001 | Checkpoint | Alcopro Inc. | 2022-09-22 |
| G354CCP084103 | Checkpoint | Alcopro Inc. | 2022-09-22 |
| G354AAB08201 | AlcoBreath Tube | Alcopro Inc. | 2022-09-22 |
| 00853464001126 | AlcoMate Core | AK Globaltech Corp | 2021-06-21 |
| 00853464001409 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001348 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001416 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001423 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001430 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001447 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001454 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001461 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001478 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001485 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001393 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001386 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001379 | AlcoMate | AK Globaltech Corp | 2020-10-06 |
| 00853464001355 | AlcoMate | AK Globaltech Corp | 2020-08-24 |
| 00853464001119 | AlcoMate | AK Globaltech Corp | 2020-08-24 |
| 00853464001102 | AlcoMate | AK Globaltech Corp | 2020-08-24 |
| 00853464001089 | AlcoMate | AK Globaltech Corp | 2020-08-24 |
| 00853464001041 | AlcoMate | AK Globaltech Corp | 2020-08-24 |
| 00850003180328 | Easy@Home Fuel Cell Breathalyzer | EASY HEALTHCARE CORPORATION | 2019-07-31 |
| 06970429840638 | co-innovation | Co-Innovation Biotech Co., Ltd | 2018-11-19 |