510(k) K243256— WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest

Substantially Equivalent

Wondfo USA Co, Ltd.

Clearance details

Applicant: Wondfo USA Co, Ltd.
Product code: 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

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