510(k) K213804— cobas SARS-CoV-2 Qualitative for use on the cobas 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: 2021-12-06
Decision date: 2022-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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