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FDA 510(k)

Shinetell PlusTM Digital Early Pregnancy Test

K-Number: K251053 · 2025-07-15

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2025-07-15
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Shinetell PlusTM Digital Early Pregnancy Test is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-07-15 under approval number K251053. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shinetell PlusTM Digital Early Pregnancy Test?

Shinetell PlusTM Digital Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-07-15. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K251053.

When was Shinetell PlusTM Digital Early Pregnancy Test approved by the FDA?

Shinetell PlusTM Digital Early Pregnancy Test received FDA 510(k) clearance on 2025-07-15, under approval number K251053.

What company makes Shinetell PlusTM Digital Early Pregnancy Test?

Shinetell PlusTM Digital Early Pregnancy Test is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for Shinetell PlusTM Digital Early Pregnancy Test?

The FDA product code for Shinetell PlusTM Digital Early Pregnancy Test is LCX.

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Related PubMed Literature

PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026) PMID: 41032887 Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study. Journal of medical Internet research (2025) PMID: 40380731 Effective Requirements Engineering in Early-Stage Digital Health Startups. Studies in health technology and informatics (2025) PMID: 40271230 When Software Becomes Medicine: Ignoring It May Soon Be Malpractice. Cureus (2025)

Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K203272Alltest Pregnancy Rapid Combo Test Cassette K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx K233417AllTest Fentanyl Urine Test Cassette K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

View all 14 devices →

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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