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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory specimen nucleic acid sars-cov-2 test
510(k) Number K231306
Device Name cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94028
Applicant Contact Caroline Sobek
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94028
Correspondent Contact Caroline Sobek
Regulation Number866.3981
Classification Product Code
QQX  
Date Received05/05/2023
Decision Date 06/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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