Cleared Traditional

Yumizen C1200 ALP, Yumizen C1200 Albumin

K191245 · HORIBA ABX SAS · Chemistry
Aug 2019
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K191245 is an FDA 510(k) clearance for the Yumizen C1200 ALP, Yumizen C1200 Albumin, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on August 30, 2019, 113 days after receiving the submission on May 9, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K191245 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2019
Decision Date August 30, 2019
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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