K241394

Substantially Equivalent

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

Applicant: Andon Health Co, Ltd.
Product code: LCX
Advisory panel: Clinical Chemistry
Date received: 2024-05-16
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

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