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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Intrinsic Factor Blocking Antibody
510(k) Number K240800
Device Name Access Intrinsic Factor Ab
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact Kate Oelberg
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact Kate Oelberg
Regulation Number862.1810
Classification Product Code
LIG  
Date Received03/25/2024
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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