510(k) clearance

Access BNP II

FDA 510(k) source

510(k) number

K262597

Applicant

Beckman Coulter, Inc.

Decision date

Oct 20, 2026

Date received

Jul 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NBC

Device type

Test, Natriuretic Peptide

Device class

Class II

Regulation

21 CFR 862.1117

Advisory committee

Clinical Chemistry

Statement or summary

Summary

Third party

N

Location

Chaska, MN, US