Elecsys Anti-HBc II— 510(k) K260046

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K260046 for Elecsys Anti-HBc II, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code SEI
Advisory panel: Microbiology
Date received: 2026-01-07
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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