Cleared Traditional

NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT

K052591 · Clinical Data, Inc. · Chemistry
Feb 2006
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K052591 is an FDA 510(k) clearance for the NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Clinical Data, Inc. (Newton, US). The FDA issued a Cleared decision on February 9, 2006, 141 days after receiving the submission on September 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K052591 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2005
Decision Date February 09, 2006
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

Similar Devices — DCK C-reactive Protein, Antigen, Antiserum, And Control

All 125
K-ASSAY CRP (Ver.2)
K242170 · Kamiya Biomedical Company, LLC · Apr 2025
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · Procise Diagnostics · Nov 2022
Yumizen C1200 CRP
K192028 · HORIBA ABX SAS · Jun 2020
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
VITROS Chemistry Products hsCRP Reagent
K160712 · Ortho-Clinical Diagnostics · Jul 2017