510(k) K240867— cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

Substantially Equivalent

Roche Molecular Systems, Inc.

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code QQX
Advisory panel: Microbiology
Date received: 2024-03-29
Decision date: 2025-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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