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510(k) K021609

RDI HS CRP KIT by Reference Diagnostics, Inc. — Product Code DCK

K021609 is an FDA 510(k) premarket notification submitted by Reference Diagnostics, Inc. for the device "RDI HS CRP KIT". The FDA issued a decision of Substantially Equivalent on June 27, 2002. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Reference Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2002
Date Received
May 16, 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 Reference Diagnostics, Inc.

  • K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (March 13, 2006)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)
  • K052148 — TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (November 9, 2005)
  • K030044 — EXTENDED RANGE HS CRP KIT, CAT NO:9200 (September 30, 2003)
  • K030772 — RDI EXTENDED RANGE CRP CALIBRATOR SET (April 11, 2003)
  • K021607 — RDI HS CRP CALIBRATOR SET (June 27, 2002)
  • K000783 — DIRECT TIBC CALIBRATOR (May 4, 2000)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)
  • K984107 — RDI DIRECT LDL CHOLESTEROL TEST (January 28, 1999)

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