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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cytomegalovirus (Cmv) Dna Quantitative Assay
510(k) Number K252481
Device Name cobas CMV
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact Sun Austin
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact Sun Austin
Regulation Number866.3180
Classification Product Code
PAB  
Date Received08/07/2025
Decision Date 11/03/2025
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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