Cleared Traditional

Shinetell PlusTM Digital Early Pregnancy Test

K251053 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry
Jul 2025
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K251053 is an FDA 510(k) clearance for the Shinetell PlusTM Digital Early Pregnancy Test, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 15, 2025, 102 days after receiving the submission on April 4, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K251053 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2025
Decision Date July 15, 2025
Days to Decision 102 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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