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FDA 510(k)

Yumizen C1200 ALP, Yumizen C1200 Albumin

K-Number: K191245 · 2019-08-30

ApplicantHORIBA ABX SAS
Decision Date2019-08-30
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Yumizen C1200 ALP, Yumizen C1200 Albumin is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2019-08-30 under approval number K191245. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yumizen C1200 ALP, Yumizen C1200 Albumin?

Yumizen C1200 ALP, Yumizen C1200 Albumin is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by HORIBA ABX SAS. The 510(k) number is K191245.

When was Yumizen C1200 ALP, Yumizen C1200 Albumin approved by the FDA?

Yumizen C1200 ALP, Yumizen C1200 Albumin received FDA 510(k) clearance on 2019-08-30, under approval number K191245.

What company makes Yumizen C1200 ALP, Yumizen C1200 Albumin?

Yumizen C1200 ALP, Yumizen C1200 Albumin is manufactured by HORIBA ABX SAS.

What is the FDA product code for Yumizen C1200 ALP, Yumizen C1200 Albumin?

The FDA product code for Yumizen C1200 ALP, Yumizen C1200 Albumin is CJE.

Other Devices by HORIBA ABX SAS

K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CT K191993Yumizen C1200 CRP K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M K192028Yumizen C1200 CRP K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

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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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