DJZ · Devices, Breath Trapping, Alcohol
Clinical Toxicology · 21 CFR 862.3050 · Class 1
Overview
| Product Code | DJZ |
|---|---|
| Device Name | Devices, Breath Trapping, Alcohol |
| Regulation | 21 CFR 862.3050 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
Identification
A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160613 | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | Jul 14, 2016 | SESE |
| K123470 | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | Pas Systems International, Inc. | Apr 29, 2013 | SESE |
| K110614 | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | Seju Engineering Co., Ltd. | Nov 21, 2011 | SESE |
| K102225 | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | Alcopro, Inc. | Apr 6, 2011 | SESE |
| K102338 | BREATHSCN PRO | Akers Biosciences, Inc. | Jan 12, 2011 | SESE |
| K100879 | CONTRALCO | Contralco | Aug 4, 2010 | SESE |
| K093143 | MISSION BREATH ALCOHOL DETECTOR | ACON Laboratories, Inc. | Jan 28, 2010 | SESE |
| K091714 | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | Nov 18, 2009 | SESE |
| K090766 | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER | Lifeloc Technologies, Inc. | Jul 23, 2009 | SESE |
| K082080 | ALCO TUBE PLUS | Alcotest Quebec | Apr 1, 2009 | SESE |
| K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | Khn Solutions, LLC | Mar 24, 2009 | SESE |
| K083801 | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 | Khn Solutions, LLC | Mar 19, 2009 | SESE |
| K082086 | KEY RING ALCOHOL BREATHALYZER | The Ashley Collection, Inc. | Dec 19, 2008 | SESE |
| K081855 | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) | Canada, Inc. | Dec 19, 2008 | SESE |
| K080848 | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR | Q3 Innovations, LLC | Jul 25, 2008 | SESE |
| K063443 | DRAEGER ALCOTEST 6510 | Drager Safety | Mar 11, 2008 | SESE |
| K072953 | REDLINE ALCOHOL BREATH TESTER | Redline Products (Pty) , Ltd. | Jan 7, 2008 | SESE |
| K071067 | BACTRACK LCD ALCOHOL DETECTOR | Khn Solutions, LLC | Sep 14, 2007 | SESE |
| K062545 | RMI LCD ALCOHOL DETECTOR | Resource Management International, LLC | Apr 9, 2007 | SESE |
| K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS | Akers Biosciences, Inc. | Dec 18, 2006 | SESE |
Top Applicants
- Khn Solutions, LLC — 4 clearances
- Akers Biosciences, Inc. — 3 clearances
- Sentech Korea Corp. — 3 clearances
- Q3 Innovations, LLC — 2 clearances
- ACON Laboratories, Inc. — 1 clearance
