Yumizen C1200 Creatinine PAP— 510(k) K193649

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K193649 for Yumizen C1200 Creatinine PAP, Substantially Equivalent on 2021-05-10. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2019-12-30
Decision date: 2021-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.