Data / Medical devices / United States / Wondfo USA Co., Ltd.
Wondfo USA Co., Ltd.: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances
Wondfo USA Co., Ltd. is registered with the FDA (registration 3016252795) in San Diego, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016252795
- Address
- 6720 Cobra Way, San Diego, CA, United States, 92121
- Owner or operator
- Wondfo USA Co., Ltd. (10028951)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- May 5, 2018
- Registered through
- 2027
- Brand names listed
- 2San 3 in 1 COVID-19 + Flu A&B Rapid Self-Test, Clarity COVID-19 / Influenza A&B Antigen Test, Clarity COVID-19 / Influenza A&B Antigen Test Control Kit, Clarity COVID-19 Antigen Test Control Kit, Clarity Influenza A&B Test, Clarity Influenza A&B Test Control Kit, Dealmed COVID-19 / Influenza A&B Antigen Test, Dealmed COVID-19 / Influenza A&B Antigen Test Control Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Contract manufacturer | accessdata.fda.gov |
| Covid-19 Multi-Analyte Antigen Device | QMN | N | Manufacturer | accessdata.fda.gov |
| Kit, Direct Antigen, Positive Control | MJZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Complaint file establishment, 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 20, 2025 | K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | SCA | Substantially Equivalent | Wondfo USA Co, Ltd. | accessdata.fda.gov |
| January 16, 2025 | K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | SCA | Substantially Equivalent | Wondfo USA Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Respiratory Virus Antigen Detection Test
- All makers of Antigens, All Groups, Streptococcus Spp.
- All makers of Kit, Direct Antigen, Positive Control
- All makers of Covid-19 Multi-Analyte Antigen Device
Updated August 20, 2025. 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.