Home / 510(k) Clearances / K024280

510(k) K024280

WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET by Wako Chemicals USA, Inc. — Product Code DCK

K024280 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on June 6, 2003. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2003
Date Received
December 23, 2002
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 Wako Chemicals USA, Inc.

  • K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, (February 23, 2011)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (July 17, 2008)
  • K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (February 23, 2007)
  • K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP (January 31, 2007)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (December 30, 2005)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (December 30, 2005)
  • DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (May 19, 2005)
  • K042551 — MULTI-CHEM CALIBRATOR A (November 16, 2004)
  • K042550 — MULTI-LIPID CALIBRATOR (November 8, 2004)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)

FDA data resources