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510(k) K052591

NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT by Clinical Data, Inc. — Product Code DCK

K052591 is an FDA 510(k) premarket notification submitted by Clinical Data, Inc. for the device "NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT". The FDA issued a decision of Substantially Equivalent on February 9, 2006. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Clinical Data, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2006
Date Received
September 21, 2005
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 Clinical Data, Inc.

  • K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55 (December 20, 2007)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)

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