Cleared Traditional

Yumizen C1200 Creatinine PAP

K193649 · HORIBA ABX SAS · Chemistry
May 2021
Decision
497d
Days
Class 2
Risk

About This 510(k) Submission

K193649 is an FDA 510(k) clearance for the Yumizen C1200 Creatinine PAP, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on May 10, 2021, 497 days after receiving the submission on December 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K193649 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2019
Decision Date May 10, 2021
Days to Decision 497 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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