Home / 510(k) Clearances / K141689

510(k) K141689

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit by Qualigen, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2015
Date Received
June 23, 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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