K251040
- 510(k) number
- K251040
- Device name
- MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2025-09-09
- Date received
- 2025-04-03
- 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: K251040.pdf
Official FDA record: K251040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.