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FDA 510(k)

ADVIA Centaur® NT-proBNPII (PBNPII)

K-Number: K220265 · 2023-09-24

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-09-24
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur® NT-proBNPII (PBNPII) 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 2023-09-24 under 510(k) number K220265. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur® NT-proBNPII (PBNPII)?

ADVIA Centaur® NT-proBNPII (PBNPII) is a medical device that received FDA 510(k) clearance on 2023-09-24. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220265.

When did ADVIA Centaur® NT-proBNPII (PBNPII) receive FDA 510(k) clearance?

ADVIA Centaur® NT-proBNPII (PBNPII) received FDA 510(k) clearance on 2023-09-24, under 510(k) number K220265.

Who is the listed applicant for ADVIA Centaur® NT-proBNPII (PBNPII)?

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® NT-proBNPII (PBNPII)?

The FDA product code for ADVIA Centaur® NT-proBNPII (PBNPII) is NBC.

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Related Devices (Code: NBC)

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.

K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K223637Elecsys proBNP II, Elecsys proBNP II STATRoche DiagnosticsK210546Elecsys proBNP II, Elecsys proBNP II STATRoche 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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