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510(k) K011958

CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT by Denka Seiken'S — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2001
Date Received
June 22, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Denka Seiken'S

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  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)
  • K981734 — VTEC-RPLA SEIKEN (September 22, 1998)

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