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FDA 510(k)

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

K-Number: K193525 · 2020-06-26

ApplicantHORIBA ABX SAS
Decision Date2020-06-26
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-26 under approval number K193525. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by HORIBA ABX SAS. The 510(k) number is K193525.

When was Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M approved by the FDA?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M received FDA 510(k) clearance on 2020-06-26, under approval number K193525.

What company makes Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is manufactured by HORIBA ABX SAS.

What is the FDA product code for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

The FDA product code for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is CZP.

Other Devices by HORIBA ABX SAS

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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