EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II— 510(k) K232864
Substantially EquivalentNantong Egens Biotechnology Co., Ltd.
FDA 510(k) clearance K232864 for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II, Substantially Equivalent on 2024-01-26. Applicant: Nantong Egens Biotechnology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nantong Egens Biotechnology Co., Ltd.
- Product code
- Product 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
- Nantong, CN
Recent devices under product code LCX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.