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 a medical device manufactured by Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2019-08-02 under approval 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. It is manufactured by Axis-Shield Diagnostics Limited. The 510(k) number is K183088.
When was ADVIA Centaur Erythropoietin (EPO) assay approved by the FDA?
ADVIA Centaur Erythropoietin (EPO) assay received FDA 510(k) clearance on 2019-08-02, under approval number K183088.
What company makes ADVIA Centaur Erythropoietin (EPO) assay?
ADVIA Centaur Erythropoietin (EPO) assay is manufactured by Axis-Shield Diagnostics Limited.
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 Devices by Axis-Shield Diagnostics Limited
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K182012ADVIA Centaur Calcitonin (CALCT) assay
Related Devices (Code: GGT)
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.