WELLlife COVID-19 Antigen Test Rx— 510(k) K251289
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K251289 for WELLlife COVID-19 Antigen Test Rx, Substantially Equivalent on 2025-10-22. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code QVF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3982
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Guangzhou, CN
Recent devices under product code QVF
view allMore clearances from Guangzhou Wondfo Biotech Co., Ltd.
view all- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
- K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
Data sourced from openFDA. This site is unofficial and independent of the FDA.