Elecsys HBsAg II quant II RxDx— 510(k) DEN260027

Unknown

Roche Diagnostics

FDA 510(k) clearance DEN260027 for Elecsys HBsAg II quant II RxDx, Unknown on 2026-10-20. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Product code SJM
Advisory panel: Unknown
Date received: 2026-06-02
Decision date: 2026-10-20
Decision: Unknown
Clearance type: Direct
Location: Indianapolis, IL, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.