Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-03-24 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K252169.

When did Access BNP II receive FDA 510(k) clearance?

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

Who is the listed applicant for Access BNP II?

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 BNP II?

The FDA product code for Access BNP II 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.

K254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P230015Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

View all 84 devices →

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.

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.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.

↑