Data / Medical devices / China / Atlas Link Technology Co., Ltd.
Atlas Link Technology Co., Ltd.: FDA-registered device maker in Langfang Hebei, China, 1 510(k) clearance
Atlas Link Technology Co., Ltd. is registered with the FDA (registration 3016849811) in Langfang Hebei, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 4, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016849811
- Address
- Xing Min Road, South Industrial Park, Langfang Hebei, China, 065500
- Owner or operator
- Atlas Link Inc. (10069679)
- Roles
- Manufacturer
- First device listed
- August 11, 2020
- Registered through
- 2027
- Brand names listed
- NOVAtest, SENSOtest
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | 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 |
|---|---|---|---|---|---|---|
| August 4, 2021 | K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | LCX | Substantially Equivalent | Atlas Link Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Reagent, Coronavirus Serological
Updated August 4, 2021. 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.