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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 K254059
Device Name Access anti-HBc IgM
Applicant
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92821
Applicant Contact Veronica Colinayo
Correspondent
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92821
Correspondent Contact Veronica Colinayo
Classification Product Code
SEI  
Date Received12/17/2025
Decision Date 03/13/2026
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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