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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2015 | Acon Laboratories, Inc. Mission
-Breath Alcohol Detector
-15 tests
- 0.08% BAC
- Blow bags included
Product Usage:
The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the Terminated |
DJZ | K093143 |
| Feb 5, 2008 | Sakar International, Inc. Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester) Terminated |
DJZ | None listed |
| Dec 23, 2005 | WNCK, Inc 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly) Terminated |
DJZ | None listed |
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