Clearance Summary
MAGLUMI 2000 HCG/ß-HCG received FDA 510(k) clearance under submission number K192547, sponsored by Shenzhen New Industries Biomedical Engineering 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 2020-01-17.
- Submission: K192547
- Applicant / Sponsor: Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2020-01-17
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.