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510(k) K152117

Dropper hsCRP High Sensitivity CRP Control by Quantimetrix Corporation — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2016
Date Received
July 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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