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510(k) K112377

BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2012
Date Received
August 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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