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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K240273
Device Name Access Free T4
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Muhammad Sheikh
Correspondent
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Muhammad Sheikh
Regulation Number862.1695
Classification Product Code
CEC  
Date Received01/31/2024
Decision Date 03/06/2024
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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