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510(k) K161140

VITROS Chemistry Products Calibrator Kit 3 by Ortho-Clinical Diagnostics, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
April 22, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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