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FDA 510(k)

ADVIA Centaur® Digoxin assay

K-Number: K193397 · 2021-07-16

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2021-07-16
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® Digoxin 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 2021-07-16 under 510(k) number K193397. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® Digoxin assay?

ADVIA Centaur® Digoxin assay is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K193397.

When did ADVIA Centaur® Digoxin assay receive FDA 510(k) clearance?

ADVIA Centaur® Digoxin assay received FDA 510(k) clearance on 2021-07-16, under 510(k) number K193397.

Who is the listed applicant for ADVIA Centaur® Digoxin 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® Digoxin assay?

The FDA product code for ADVIA Centaur® Digoxin assay is KXT.

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Related Devices (Code: KXT)

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.

K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac 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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