Data / Medical devices / South Korea / Da Tech Co Ltd
Da Tech Co Ltd: FDA-registered device maker in Incheon, South Korea, 2 510(k) clearances
Da Tech Co Ltd is registered with the FDA (registration 3007343307) in Incheon, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007343307
- Address
- 13, Seounsandan-ro 4-gil Gyeyang-gu, Incheon, South Korea, 21072
- Owner or operator
- DA TECH CO LTD (10027379)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 31, 2008
- Registered through
- 2026
- Brand names listed
- BACTRACK Element, BACTRACK S30, BACTRACK S70, BACTRACK S75, BACTRACK S78, BACTRACK S80, BACTRACK S82, Bactrack Select S50
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2009 | K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | DJZ | Substantially Equivalent | Khn Solutions, LLC | accessdata.fda.gov |
| October 30, 2006 | K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 | DJZ | Substantially Equivalent | Sentech Korea Corp. | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.