Home / 510(k) Clearances / K160370

510(k) K160370

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2016
Date Received
February 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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