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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
510(k) Number K252424
Device Name Anti-HCV Next
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Cp1
Abbott Park,  IL  60064
Applicant Contact Linda Sohn
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Cp1
Abbott Park,  IL  60064
Correspondent Contact Linda Sohn
Regulation Number866.3169
Classification Product Code
MZO  
Date Received08/01/2025
Decision Date 04/28/2026
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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