K243573

Substantially Equivalent

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

Applicant: Assure Tech., LLC
Product code: LCX
Advisory panel: Clinical Chemistry
Date received: 2024-11-19
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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