FDA 510(k) Applications Submitted by Kate Oelberg

FDA 510(k) Number Submission Date Device Name Applicant
K240182 01/23/2024 Access EPO Beckman Coulter Inc
K240403 02/09/2024 Access BR Monitor Beckman Coulter, Inc.
K240800 03/25/2024 Access Intrinsic Factor Ab Beckman Coulter Inc
K240996 04/11/2024 Access Thyroglobulin Antibody II Beckman Coulter Inc
K231832 06/22/2023 Access Myoglobin Beckman Coulter, Inc
K221990 07/06/2022 Access Total ▀hCG (5th IS) Beckman Coulter, Inc
K232904 09/18/2023 Access Ostase Beckman Coulter
K222881 09/22/2022 Access hsTnI Beckman Coulter Inc
K233480 10/26/2023 Access SHBG Beckman Coulter Inc.
K223503 11/22/2022 Access 25(OH) Vitamin D Total Beckman Coulter Inc
K223679 12/08/2022 Access AMH Beckman Coulter Inc
K234052 12/21/2023 Access Ferritin Beckman Coulter, Inc


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