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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hepatitis A Test (Antibody And Igm Antibody)
510(k) Number K260048
Device Name Elecsys Anti-HAV IgM
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IL  46256
Applicant Contact Samantha Logan
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IL  46256
Correspondent Contact Samantha Logan
Regulation Number866.3310
Classification Product Code
LOL  
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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