K242135
- 510(k) number
- K242135
- Device name
- Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- Applicant
- Nanjing Synthgene Medical Technology Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2025-01-31
- Date received
- 2024-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K242135.pdf
Official FDA record: K242135
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.