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FDA 510(k)

ADVIA Centaur CEA Assay

K-Number: K200215 · 2020-04-13

ApplicantSiemens Healthcare Disgnostics, Inc.
Decision Date2020-04-13
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur CEA Assay is a medical device manufactured by Siemens Healthcare Disgnostics, Inc.. It received FDA 510(k) clearance on 2020-04-13 under approval number K200215. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur CEA Assay?

ADVIA Centaur CEA Assay is a medical device that received FDA 510(k) clearance on 2020-04-13. It is manufactured by Siemens Healthcare Disgnostics, Inc.. The 510(k) number is K200215.

When was ADVIA Centaur CEA Assay approved by the FDA?

ADVIA Centaur CEA Assay received FDA 510(k) clearance on 2020-04-13, under approval number K200215.

What company makes ADVIA Centaur CEA Assay?

ADVIA Centaur CEA Assay is manufactured by Siemens Healthcare Disgnostics, Inc..

What is the FDA product code for ADVIA Centaur CEA Assay?

The FDA product code for ADVIA Centaur CEA Assay is DHX.

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Official Source

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

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