Cleared Traditional

Yumizen C1200 CRP

K191993 · HORIBA ABX SAS · Chemistry
Oct 2019
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K191993 is an FDA 510(k) clearance for the Yumizen C1200 CRP, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on October 3, 2019, 70 days after receiving the submission on July 25, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K191993 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2019
Decision Date October 03, 2019
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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