Cleared Special

IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)

K071017 · Siemens Medical Solutions Diagnostics · Chemistry

May 2007

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K071017 is an FDA 510(k) clearance for the IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS), a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by Siemens Medical Solutions Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on May 2, 2007, 22 days after receiving the submission on April 10, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K071017 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2007
Decision Date	May 02, 2007
Days to Decision	22 days
Submission Type	Special
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.