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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-16 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K193397.
When was ADVIA Centaur® Digoxin assay approved by the FDA?
ADVIA Centaur® Digoxin assay received FDA 510(k) clearance on 2021-07-16, under approval number K193397.
What company makes ADVIA Centaur® Digoxin assay?
ADVIA Centaur® Digoxin assay is manufactured by Siemens Healthcare Diagnostics, Inc..
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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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.