Cleared Traditional

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

K183375 · Horiba, Ltd. · Chemistry

Feb 2019

Decision

68d

Days

Class 1

Risk

About This 510(k) Submission

K183375 is an FDA 510(k) clearance for the Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Horiba, Ltd. (Kyoto, JP). The FDA issued a Cleared decision on February 12, 2019, 68 days after receiving the submission on December 6, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number	K183375 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2018
Decision Date	February 12, 2019
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2160