Source document or public record
FDA 510(k) K251053 — Shinetell PlusTM Digital Early Pregnancy Test
FDA 510(k) index record K251053. Device: Shinetell PlusTM Digital Early Pregnancy Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-07-15.
Source
"device_name": "Shinetell PlusTM Digital Early Pregnancy Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251053.
Device name: Shinetell PlusTM Digital Early Pregnancy Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd..
Decision date: 2025-07-15. Decision wording: Substantially Equivalent.
Product code: LCX. Regulation: 21 CFR 862.1155. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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