Cleared Traditional

IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT

K071002 · Beckman Coulter, Inc. · Chemistry

Jun 2007

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K071002 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT, a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 21, 2007, 73 days after receiving the submission on April 9, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K071002 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2007
Decision Date	June 21, 2007
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NQD — Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5270
Definition	In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.