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FDA 510(k)

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

K-Number: K191562 · 2020-03-06

ApplicantHORIBA ABX SAS
Decision Date2020-03-06
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-03-06 under approval number K191562. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor?

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by HORIBA ABX SAS. The 510(k) number is K191562.

When was Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor approved by the FDA?

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor received FDA 510(k) clearance on 2020-03-06, under approval number K191562.

What company makes Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor?

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor is manufactured by HORIBA ABX SAS.

What is the FDA product code for Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor?

The FDA product code for Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor is DBF.

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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