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510(k) K142993

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument by Orion Diagnostica, OY — Product Code DCK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 2016
Date Received: October 16, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: C-Reactive Protein, Antigen, Antiserum, And Control
Device Class: Class II
Regulation Number: 866.5270
Review Panel: IM
Submission Type

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K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)
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