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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K243455
Device Name cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact Claudia Machay
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact Claudia Machay
Regulation Number866.3981
Classification Product Code
QOF  
Date Received11/07/2024
Decision Date 07/31/2025
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
Predetermined Change
Control Plan Authorized		 No
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