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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, vitamin d
510(k) Number K223503
Device Name Access 25(OH) Vitamin D Total
Applicant
Beckman Coulter Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318 -1084
Applicant Contact Kate Oelberg
Correspondent
Beckman Coulter Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318 -1084
Correspondent Contact Kate Oelberg
Regulation Number862.1825
Classification Product Code
MRG  
Date Received11/22/2022
Decision Date 01/19/2023
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
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