Cleared Traditional

Tina-quant C-Reactive Protein IV

K192072 · Roche Diagnostics Operations (Rdo) · Immunology
Feb 2020
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K192072 is an FDA 510(k) clearance for the Tina-quant C-Reactive Protein IV, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on February 21, 2020, 203 days after receiving the submission on August 2, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K192072 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2019
Decision Date February 21, 2020
Days to Decision 203 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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