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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, cortisol
510(k) Number K223038
Device Name Access Cortisol
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Kuljeet Kaur
Correspondent
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Kuljeet Kaur
Regulation Number862.1205
Classification Product Code
CGR  
Date Received09/29/2022
Decision Date 02/08/2023
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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