Cleared Traditional

CRP Vario

K173833 · SENTINEL CH. SpA · Chemistry

Sep 2018

Decision

283d

Days

Class 2

Risk

About This 510(k) Submission

K173833 is an FDA 510(k) clearance for the CRP Vario, a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on September 27, 2018, 283 days after receiving the submission on December 18, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K173833 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2017
Decision Date	September 27, 2018
Days to Decision	283 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.