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510(k) K201256

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge by Procise Diagnostics — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2022
Date Received
May 11, 2020
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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