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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K233480
Device Name Access SHBG
Applicant
Beckman Coulter Inc.
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Kate Oelberg
Correspondent
Beckman Coulter Inc.
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Kate Oelberg
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received10/26/2023
Decision Date 02/08/2024
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
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