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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 K253687
Device Name Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434)
Applicant
Beckman Coulter, Inc.
1000 Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact Fatima Pacheco
Correspondent
Beckman Coulter, Inc.
1000 Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact Fatima Pacheco
Classification Product Code
SEI  
Date Received11/21/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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