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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 K243846
Device Name Access anti-HAV
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
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Codes
JIT   QCH  
Date Received12/16/2024
Decision Date 09/09/2025
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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