Cleared Traditional

Atellica? CH High Sensitivity C-Reactive Protein 2 (hCRP2)

K233242 · Siemens Healthcare Diagnostics, Inc. · Chemistry

Jan 2024

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K233242 is an FDA 510(k) clearance for the Atellica? CH High Sensitivity C-Reactive Protein 2 (hCRP2), a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on January 18, 2024, 112 days after receiving the submission on September 28, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K233242 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	January 18, 2024
Days to Decision	112 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.