Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe— 510(k) K191396

Name: FDA 510(k) clearance K191396
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K191396 for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe, Substantially Equivalent on 2019-07-26. Applicant: HORIBA ABX SAS. Device class: 2.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2019-05-24
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJY

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K120626 — EON CALCIUM REGENT2012-08-22

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