BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
FDA 510(k) clearance K160370 · decided 2016-06-09
Clearance details
- K-number
- K160370
- Device name
- BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-10
- Decision date
- 2016-06-09
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.