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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K192777.

When did ADVIA Centaur CA 15-3 assay receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur CA 15-3 assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche DiagnosticsK171605Elecsys CA 15-3 IIRoche Diagnostics

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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