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510(k) K030546

CRP (II) CALIBRATORS by Denka Seiken Co., Ltd. — Product Code JIS

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
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
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)
  • K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT (June 2, 2003)

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