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510(k) K030545

CRP-LATEX (II)X2 SEIKEN ASSAY KIT by Denka Seiken Co., Ltd. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2003
Date Received
February 20, 2003
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

Other clearances by Denka Seiken Co., Ltd.

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  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041090 — HDL-EX SEIKEN ASSAY KIT (October 29, 2004)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)

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