510(k) K250117— FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

Substantially Equivalent

Assure Tech., LLC

Clearance details

Applicant: Assure Tech., LLC
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2025-01-16
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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