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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Qualitative And Quantitative Hepatitis B Virus Antibody Assays
510(k) Number K260046
Device Name Elecsys Anti-HBc II
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact Ailsa Grieve
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact Ailsa Grieve
Classification Product Code
SEI  
Subsequent Product Code
JJX  
Date Received01/07/2026
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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