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510(k) K163433

VITROS Chemistry Products GLU Slides by Ortho Clinical Diagnostics — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2017
Date Received
December 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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