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510(k) K002558

K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE by Kamiya Biomedical Co. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
August 14, 2000
Clearance Type
Special
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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