510(k) clearance

Access NT-proBNP

FDA 510(k) source

510(k) number

K262109

Applicant

Beckman Coulter, Inc.

Decision date

Sep 21, 2026

Date received

Jun 23, 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