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

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.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code CJY
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

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