Cleared Traditional

Shinetell Digital Pregnancy Test

K241978 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry
Aug 2024
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K241978 is an FDA 510(k) clearance for the Shinetell Digital 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 August 13, 2024, 39 days after receiving the submission on July 5, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K241978 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2024
Decision Date August 13, 2024
Days to Decision 39 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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