Clearance Summary
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer received FDA 510(k) clearance under submission number K160370, 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 2016-06-09.
- Submission: K160370
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 2016-06-09
Classification & Regulation
This clearance is catalogued under FDA product code JGS and 21 CFR 862.1665, within the Clinical Chemistry review panel as a Class II device.