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510(k) K073157

VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 by Ortho-Clinical Diagnostics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2007
Date Received
November 8, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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