Cleared Special

RCRP Flex reagent cartridge

K221119 · Siemens Healthcare Diagnostics, Inc. · Immunology
Mar 2023
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K221119 is an FDA 510(k) clearance for the RCRP Flex reagent cartridge, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on March 17, 2023, 333 days after receiving the submission on April 18, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K221119 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2022
Decision Date March 17, 2023
Days to Decision 333 days
Submission Type Special
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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