K243256

Substantially Equivalent

WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest

Applicant: Wondfo USA Co, Ltd.
Product code: SCA
Advisory panel: Microbiology
Date received: 2024-10-15
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.