Cleared Traditional

CardioPhase? hsCRP

K232624 · Siemens Healthcare Diagnostic Products GmbH · Immunology
Nov 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K232624 is an FDA 510(k) clearance for the CardioPhase? hsCRP, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on November 27, 2023, 90 days after receiving the submission on August 29, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K232624 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2023
Decision Date November 27, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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