K251563

Substantially Equivalent

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

Applicant: Wondfo USA Co, Ltd.
Product code: SCA
Advisory panel: Microbiology
Date received: 2025-05-22
Decision date: 2025-08-20
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.