510(k) K252280— Elecsys Anti-SARS-CoV-2 S

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code QVP
Advisory panel: Microbiology
Date received: 2025-07-22
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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