Cleared Traditional

iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip

K241394 · Andon Health Co, Ltd. · Chemistry
Dec 2024
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K241394 is an FDA 510(k) clearance for the iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 20, 2024, 218 days after receiving the submission on May 16, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K241394 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2024
Decision Date December 20, 2024
Days to Decision 218 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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