Clearance Summary
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream received FDA 510(k) clearance under submission number K193132, sponsored by Hangzhou Clongene Biotech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2019-12-11.
- Submission: K193132
- Applicant / Sponsor: Hangzhou Clongene Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2019-12-11
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.