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

Name: FDA 510(k) clearance K250117
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K250117 for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette, Substantially Equivalent on 2025-02-13. Applicant: Assure Tech., LLC. Device class: 2.

Clearance details

Applicant: Assure Tech., LLC
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2025-01-16
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

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K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15
K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip2024-12-20

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