Accutest Breath Alcohol Detector
Breath Alcohol Detector, .02 % BAC.
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (2), Hunan (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dong Guan EEK Electronic Technology Co., Limited | Dong Guan | Guangdong | Contract manufacturer | 2 |
| Fujian Ruili Electronics Co., Ltd. | Ningde | Fujian | Contract manufacturer | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Hanwei Electronics Group Corporation | Zhengzhou | Henan | Contract manufacturer | 1 |
| Sunton Electronics Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 1 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changsha U DE Toptech Electronic Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Rayco Electronic Ltd. | Dong Guan | Guangdong | Manufacturer | 2 |
| Shenzhen Well Electric Co., Limited | Shenzhen | Guangdong | Manufacturer | 2 |
Showing 12 of 16. All 16 manufacturers in China registered for Devices, Breath Trapping, Alcohol
Record
| Listed by | Jant Pharmacal Corp., United States |
|---|---|
| FDA product code | DJZ |
| Device type | Devices, Breath Trapping, Alcohol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3050 |
| Establishment | Complaint-file establishment |
| 510(k) | K093143 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DS95AC220 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soberlink | Soberlink Healthcare LLC | 7 |
| Checkpoint | AlcoPro Inc | 6 |
| AlcoBreath Tube | AlcoPro Inc | 4 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Easy@Home Fuel Cell Breathalyzer | Easy Healthcare Corporation | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Acon Laboratories, Inc. | 510(k) number | 2015-06-17 | Class III | Labeling False and Misleading | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. | 1,283 kits | 2015-12-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.