Elecsys EBV EBNA IgG— 510(k) K260221

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K260221 for Elecsys EBV EBNA IgG, Substantially Equivalent on 2026-10-02. Applicant: Roche Diagnostics. Device class: 1.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2026-01-26
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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