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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K232791
Device Name Access Intact PTH
Applicant
Beckman Coulter Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Neha Desai
Correspondent
Beckman Coulter Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Neha Desai
Regulation Number862.1545
Classification Product Code
CEW  
Date Received09/11/2023
Decision Date 03/01/2024
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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