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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-07-15 under 510(k) 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. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K251053.

When did Shinetell PlusTM Digital Early Pregnancy Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Shinetell PlusTM Digital Early Pregnancy Test?

The FDA 510(k) record lists Hangzhou AllTest Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hangzhou AllTest Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260342AllTest Strep A Rapid TestK252607AllTest Urinary Tract Infection TestK250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK242576AllTest Viral Transport MediumK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupK242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)Anhui Deepblue Medical Technology Co., Ltd.

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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