Clearance Summary
Macro & Micro-Test HCG Pregnancy Test Midstream received FDA 510(k) clearance under submission number K230741, sponsored by Jiangsu Macro & Micro-Test Med-Tech 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 2023-10-13.
- Submission: K230741
- Applicant / Sponsor: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2023-10-13
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.