Clearance Summary
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K140690, sponsored by Shenzhen Mindray Bio-Medical Electronics 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 2014-09-02.
- Submission: K140690
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 2014-09-02
Classification & Regulation
This clearance is catalogued under FDA product code CDQ and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.