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FDA 510(k)

Access BNP II

K-Number: K252169 · 2026-03-24

ApplicantBeckman Coulter, Inc.
Decision Date2026-03-24
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access BNP II is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-03-24 under approval number K252169. 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 BNP II?

Access BNP II is a medical device that received FDA 510(k) clearance on 2026-03-24. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K252169.

When was Access BNP II approved by the FDA?

Access BNP II received FDA 510(k) clearance on 2026-03-24, under approval number K252169.

What company makes Access BNP II?

Access BNP II is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access BNP II?

The FDA product code for Access BNP II 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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