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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic separation, alkaline phosphatase isoenzymes
510(k) Number K232904
Device Name Access Ostase
Applicant
Beckman Coulter
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Kate Oelberg
Correspondent
Beckman Coulter
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Kate Oelberg
Regulation Number862.1050
Classification Product Code
CIN  
Date Received09/18/2023
Decision Date 04/15/2024
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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