Clearance Summary
BS-200 CHEMISTRY ANALYZER, MODE BS-200 received FDA 510(k) clearance under submission number K072018, 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 2008-02-01.
- Submission: K072018
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2008-02-01
Classification & Regulation
This clearance is catalogued under FDA product code CFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.