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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K251053

Shinetell PlusTM Digital Early Pregnancy Test · Hangzhou AllTest Biotech Co., Ltd. · decided 2025-07-15 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Shinetell Plus Digital Pregnancy Test1Hangzhou AllTest Biotech Co., Ltd.LCX06936983197991
Shinetell Plus Digital Pregnancy Test1Hangzhou AllTest Biotech Co., Ltd.LCX06936983198004
Shinetell Plus Digital Pregnancy Test1Hangzhou AllTest Biotech Co., Ltd.LCX06936983197984
Shinetell Plus Digital Pregnancy Test1Hangzhou AllTest Biotech Co., Ltd.LCX06936983198011
Atida DIGITAL EARLY PREGNANCY TESTEKA02ST-HCG-USACESO LABORATORIES INC.LCX00810164510709