Cleared Traditional

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

K243573 · Assure Tech., LLC · Chemistry
Jan 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K243573 is an FDA 510(k) clearance for the FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on January 15, 2025, 57 days after receiving the submission on November 19, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K243573 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2024
Decision Date January 15, 2025
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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