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FDA 510(k)

ADVIA Centaur CA 15-3 assay

K-Number: K192777 · 2019-11-22

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-11-22
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur CA 15-3 assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K192777. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur CA 15-3 assay?

ADVIA Centaur CA 15-3 assay is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192777.

When was ADVIA Centaur CA 15-3 assay approved by the FDA?

ADVIA Centaur CA 15-3 assay received FDA 510(k) clearance on 2019-11-22, under approval number K192777.

What company makes ADVIA Centaur CA 15-3 assay?

ADVIA Centaur CA 15-3 assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur CA 15-3 assay?

The FDA product code for ADVIA Centaur CA 15-3 assay is MOI.

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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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