Shinetell PlusTM Digital Early Pregnancy Test— 510(k) K251053
Substantially EquivalentHangzhou AllTest Biotech Co., Ltd.
FDA 510(k) clearance K251053 for Shinetell PlusTM Digital Early Pregnancy Test, Substantially Equivalent on 2025-07-15. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code LCX
view all- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
- K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
More clearances from Hangzhou AllTest Biotech Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.