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510(k) K011958

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

K011958 is an FDA 510(k) premarket notification submitted by Denka Seiken'S for the device "CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT". The FDA issued a decision of Substantially Equivalent on December 4, 2001. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Denka Seiken'S has at least 3 other 510(k) clearances on record.

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

  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)
  • K981734 — VTEC-RPLA SEIKEN (September 22, 1998)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)

FDA data resources