Cleared Special

CardioPhase? hsCRP

K212559 · Siemens Healthcare Diagnostics Products GmbH · Chemistry

Dec 2022

Decision

490d

Days

Class 2

Risk

About This 510(k) Submission

K212559 is an FDA 510(k) clearance for the CardioPhase? hsCRP, a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code NQD), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on December 16, 2022, 490 days after receiving the submission on August 13, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K212559 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2021
Decision Date	December 16, 2022
Days to Decision	490 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.