510(k) clearance

Elecsys HBsAg II quant II RxDx

FDA 510(k) source

510(k) number

DEN260027

Applicant

Roche Diagnostics

Decision date

Oct 20, 2026

Date received

Jun 2, 2026

Decision

Unknown

Clearance type

Direct

Product code

SJM

Advisory committee

Unknown

Third party

N

Location

Indianapolis, IL, US