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FDA 510(k)

ADVIA Centaur Erythropoietin (EPO) assay

K-Number: K183088 · 2019-08-02

ApplicantAxis-Shield Diagnostics Limited
Decision Date2019-08-02
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Erythropoietin (EPO) assay is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K183088. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Erythropoietin (EPO) assay?

ADVIA Centaur Erythropoietin (EPO) assay is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K183088.

When did ADVIA Centaur Erythropoietin (EPO) assay receive FDA 510(k) clearance?

ADVIA Centaur Erythropoietin (EPO) assay received FDA 510(k) clearance on 2019-08-02, under 510(k) number K183088.

Who is the listed applicant for ADVIA Centaur Erythropoietin (EPO) assay?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Erythropoietin (EPO) assay?

The FDA product code for ADVIA Centaur Erythropoietin (EPO) assay is GGT.

Other records listing Axis-Shield Diagnostics Limited as applicant

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K253539Alere NT-proBNP for Alinity iK241176Alere NT-proBNP for Alinity i Reagent KitK233541ARCHITECT Active-B12 (Holotranscobalamin)K182012ADVIA Centaur Calcitonin (CALCT) assayK172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayK153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

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Related Devices (Code: GGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240182Access EPOBeckman Coulter, Inc.

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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