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510(k) K183375

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode by Horiba, Ltd. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2019
Date Received
December 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Horiba, Ltd.

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  • K110035 — INDIKO (June 28, 2011)
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  • K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (November 13, 2006)
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