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FDA 510(k)

Access NT-proBNP

K-Number: K232164 · 2024-04-12

ApplicantBeckman Coulter, Inc.
Decision Date2024-04-12
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access NT-proBNP is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232164. 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 Access NT-proBNP?

Access NT-proBNP is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K232164.

When did Access NT-proBNP receive FDA 510(k) clearance?

Access NT-proBNP received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232164.

Who is the listed applicant for Access NT-proBNP?

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

What is the FDA product code for Access NT-proBNP?

The FDA product code for Access NT-proBNP is NBC.

Other records listing Beckman Coulter, Inc. as applicant

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.

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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.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, 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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