Data / Medical devices / United States / Cordx Labs, Inc.
Cordx Labs, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 5 510(k) clearances
Cordx Labs, Inc. is registered with the FDA (registration 3034405508) in Alpharetta, GA, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034405508
- Address
- 5900 Windward Pkwy Ste 335, Alpharetta, GA, United States, 30005
- Owner or operator
- CorDx Labs, Inc. (10092206)
- Roles
- Complaint file establishment
- First device listed
- December 17, 2024
- Registered through
- 2026
- Brand names listed
- @AL21 All-Purpose First Aid Kit, @AL21 Arm Blood Pressure Monitor, @AL21 Finger Pulse Oximeter, @AL21 Infrared Thermometer, @AL21 Insect Bite Healer, @AL21 Upper Arm Blood Pressure Monitor, CORDX @AL21 Finger Pulse Oximeter, CorDx @AL21 Arm Blood Pressure Monitor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Complaint file establishment | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment | accessdata.fda.gov |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 1, 2026 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | QVF | Substantially Equivalent | CorDx, Inc. | accessdata.fda.gov |
| July 26, 2023 | K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K221798 | Finger Pulse Oximeter, Model: X1906P | DQA | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| January 7, 2022 | K210564 | Infrared Thermometer | FLL | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| October 15, 2021 | K210563 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- All makers of First Aid Kit Without Drug
- All makers of Pad, Heating, Powered
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated June 1, 2026. 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.