BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
FDA 510(k) clearance K140690 · decided 2014-09-02
Clearance details
- K-number
- K140690
- Device name
- BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-19
- Decision date
- 2014-09-02
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- CDQ
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.