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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 K213804
Device Name cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Applicant Contact Rita Hoady
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Correspondent Contact Rita Hoady
Regulation Number866.3981
Classification Product Code
QQX  
Date Received12/06/2021
Decision Date 10/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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