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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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