Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M— 510(k) K193525

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K193525 for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M, Substantially Equivalent on 2020-06-26. Applicant: HORIBA ABX SAS.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code CZP
Advisory panel: Immunology
Date received: 2019-12-19
Decision date: 2020-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier Cedex 4, FR

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