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510(k) K060139

CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 by Diagnostic Chemicals , Ltd. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
January 19, 2006
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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  • K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (November 23, 2004)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)

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