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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 a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-04-12 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K232164.

When was Access NT-proBNP approved by the FDA?

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

What company makes Access NT-proBNP?

Access NT-proBNP is manufactured by Beckman Coulter, Inc..

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

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

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Related Devices (Code: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc. K223637Elecsys 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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