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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings
510(k) Number K223783
Device Name cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Applicant Contact Aradhana Karthikeyan
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Correspondent Contact Alicja Stradomska
Regulation Number866.3982
Classification Product Code
QWR  
Date Received12/16/2022
Decision Date 12/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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