WELLlife COVID-19 Antigen Test Rx— 510(k) K251289

Substantially Equivalent

Guangzhou 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..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code QVF
Advisory panel: Microbiology
Date received: 2025-04-25
Decision date: 2025-10-22
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Guangzhou, CN

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