510(k) K140690
K140690 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 2, 2014. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2014
- Date Received
- March 19, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type