K251053
- 510(k) number
- K251053
- Device name
- Shinetell PlusTM Digital Early Pregnancy Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2025-07-15
- Date received
- 2025-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251053.pdf
Official FDA record: K251053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.