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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K223590
Device Name Access Folate Assay
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeline Dr.
Chaska,  MN  55318
Applicant Contact Dr. Kuljeet Kaur
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeline Dr.
Chaska,  MN  55318
Correspondent Contact Dr. Kuljeet Kaur
Regulation Number862.1295
Classification Product Code
CGN  
Date Received12/01/2022
Decision Date 08/23/2023
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
Predetermined Change
Control Plan Authorized		 No
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