Cleared Traditional

ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

K081294 · Siemens Healthcare Diagnostics, Inc. · Chemistry

Jul 2008

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K081294 is an FDA 510(k) clearance for the ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS, a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 29, 2008, 83 days after receiving the submission on May 7, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K081294 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2008
Decision Date	July 29, 2008
Days to Decision	83 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.