Cleared Special

CRP Vario

K192118 · SENTINEL CH. SpA · Immunology
Nov 2019
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K192118 is an FDA 510(k) clearance for the CRP Vario, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on November 8, 2019, 94 days after receiving the submission on August 6, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K192118 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2019
Decision Date November 08, 2019
Days to Decision 94 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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