Elecsys Anti-SARS-CoV-2— 510(k) K253839

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K253839 for Elecsys Anti-SARS-CoV-2, Substantially Equivalent on 2025-12-17. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code QVP
Advisory panel: Microbiology
Date received: 2025-12-01
Decision date: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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