BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer— 510(k) K160370
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearance K160370 for BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer, Substantially Equivalent on 2016-06-09. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.