Yumizen C1200 ALP, Yumizen C1200 Albumin— 510(k) K191245

Name: FDA 510(k) clearance K191245
Creator: U.S. Food and Drug Administration
Published: 2019-08-30

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K191245 for Yumizen C1200 ALP, Yumizen C1200 Albumin, Substantially Equivalent on 2019-08-30. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2019-05-09
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

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