Data / Medical devices / United States / CorDx, Inc.
CorDx, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 6 510(k) clearances
CorDx, Inc. is registered with the FDA (registration 3031823359) in Alpharetta, GA, United States. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031823359
- Address
- 5900 Windward Pkwy, Alpharetta, GA, United States, 30005
- Owner or operator
- CorDx (10050914)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 15, 2016
- Registered through
- 2027
- Brand names listed
- ACCU NEWS Multi-Drug Screen Test, ACCU NEWS Ovulation Test + Pregnancy Test Combo, ACCU NEWS Pregnancy Test Cassette, ACCU NEWS Pregnancy Test Midstream, ACCU NEWS Pregnancy Test Strip, CorDx COVID-19 Ag Test, CorDx Tyfast COVID-19 Ag Rapid Test, CorDx Tyfast COVID-19 Ag Rapid Test Rx and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 14, 2026 | K262432 | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test | SCA | Substantially Equivalent | CorDx, Inc. | accessdata.fda.gov |
| June 1, 2026 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | QVF | Substantially Equivalent | CorDx, Inc. | accessdata.fda.gov |
| June 21, 2024 | K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | QYT | Substantially Equivalent | CorDx, Inc. | accessdata.fda.gov |
| March 21, 2019 | K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | NGL | Substantially Equivalent | Hangzhou Clongene Biotech Co., Ltd. | accessdata.fda.gov |
| April 15, 2016 | K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | DKZ | Substantially Equivalent | Coretests, Inc. | accessdata.fda.gov |
| October 2, 2015 | K150063 | One Step hCG Pregnancy Test | LCX | Substantially Equivalent | Coretests, Inc. | accessdata.fda.gov |
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Updated October 14, 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.