K232864
- 510(k) number
- K232864
- Device name
- EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
- Applicant
- Nantong Egens Biotechnology Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-01-26
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K232864.pdf
Official FDA record: K232864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.