Home › Device types › DJZ
Devices, Breath Trapping, Alcohol
FDA product code DJZ · Class 1 · Clinical Toxicology
39
Registered devices
12
Adverse events
3
Recalls
28
510(k) clearances
Devices with this code
AlcoMate — AK Globaltech CorpAlcoMate — AK Globaltech CorpAlcoMate — AK Globaltech CorpAlcoBreath Tube — Alcopro Inc.AlcoMate — AK Globaltech CorpAlcoMate — AK Globaltech CorpAlcoMate — AK Globaltech CorpSOBERLINK — SOBERLINK HEALTHCARE LLCAlcoMate — AK Globaltech CorpAlcoMate Core — AK Globaltech CorpAlcoMate — AK Globaltech CorpAlcoBreath Tube — Alcopro Inc.SOBERLINK — SOBERLINK HEALTHCARE LLCSOBERLINK — SOBERLINK HEALTHCARE LLCco-innovation — Co-Innovation Biotech Co., LtdAlcoBreath Tube — Alcopro Inc.AlcoMate — AK Globaltech CorpSOBERLINK — SOBERLINK HEALTHCARE LLCAlcoMate — AK Globaltech CorpAlcoBreath Tube — Alcopro Inc.AlcoMate — AK Globaltech CorpSOBERLINK — SOBERLINK HEALTHCARE LLCAlcoMate — AK Globaltech CorpCheckpoint — Alcopro Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-17 | Acon Laboratories, Inc. | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. |
| 2007-11-30 | Sakar International, Inc. | Marketed without a 510(k) |
| 2005-11-30 | WNCK, Inc | Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff. |
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