MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test— 510(k) K251040
Substantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.
FDA 510(k) clearance K251040 for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test, Substantially Equivalent on 2025-09-09. Applicant: Guangzhou Decheng Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Decheng Biotechnology 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
- Guangzhou, CN
Recent devices under product code LCX
view all- K251053 — Shinetell PlusTM Digital Early 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 Guangzhou Decheng Biotechnology Co., Ltd.
view all- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
- K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
- K240643 — MissLan® Early Detection Pregnancy Test Strip +2 more
- K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx
- K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Data sourced from openFDA. This site is unofficial and independent of the FDA.