Cleared Traditional

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

K191396 · HORIBA ABX SAS · Chemistry
Jul 2019
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K191396 is an FDA 510(k) clearance for the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on July 26, 2019, 63 days after receiving the submission on May 24, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K191396 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2019
Decision Date July 26, 2019
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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