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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
510(k) Number K221007
Device Name cobas HCV
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Applicant Contact Ashley Malich
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Correspondent Contact Ashley Malich
Regulation Number866.3170
Classification Product Code
MZP  
Date Received04/05/2022
Decision Date 11/04/2022
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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