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510(k) K003851

BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 by Biocheck, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
December 12, 2000
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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