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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 K252102
Device Name Alinity m HCV
Applicant
Abbott Molecular, Inc.
1350 E. Touhy Ave.
Des Plaines,  IL  60018
Applicant Contact Jennifer Peterson
Correspondent
Abbott Molecular, Inc.
1350 E. Touhy Ave.
Des Plaines,  IL  60018
Correspondent Contact Jennifer Peterson
Regulation Number866.3170
Classification Product Code
MZP  
Date Received07/03/2025
Decision Date 09/25/2025
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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