Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Apr 22, 2024
Access EPO
Hematology
90d
Cleared
Apr 12, 2024
Access NT-proBNP
Chemistry
266d
Cleared
Mar 20, 2024
Access Ferritin
Immunology
90d
Cleared
Mar 06, 2024
Access Free T4
Chemistry
35d
Cleared
Mar 01, 2024
Access Intact PTH
Chemistry
172d
Cleared
Feb 16, 2024
Access CK-MB
Chemistry
59d
Cleared
Feb 08, 2024
Access SHBG
Chemistry
105d
Cleared
Dec 18, 2023
Access hsTnI
Chemistry
452d
Cleared
Dec 04, 2023
Access hsTnI
Chemistry
270d
Cleared
Nov 22, 2023
DxFLEX Flow Cytometer
Immunology
86d
Cleared
Sep 26, 2023
Access Thyroglobulin Antibody II
Immunology
692d
Cleared
Sep 22, 2023
Access CEA
Immunology
267d
Cleared
Sep 18, 2023
Access Myoglobin
Chemistry
88d
Cleared
Sep 15, 2023
Access Thyroglobulin
Immunology
529d
Cleared
Aug 23, 2023
Access Folate Assay
Chemistry
265d
Cleared
Apr 26, 2023
Access PCT
Microbiology
210d
Cleared
Apr 05, 2023
MicroScan Prompt Inoculation System-D
Microbiology
317d
Cleared
Feb 08, 2023
Access Cortisol
Chemistry
132d
Cleared
Feb 03, 2023
Access AMH
Chemistry
57d
Cleared
Jan 19, 2023
Access 25(OH) Vitamin D Total
Chemistry
58d
Cleared
Jan 13, 2023
Access Testosterone
Chemistry
65d
Cleared
Dec 27, 2022
Access Total ßhCG (5th IS)
Chemistry
174d
Cleared
Dec 23, 2022
Access Vitamin B12
Chemistry
59d
Cleared
Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Chemistry
196d
Cleared
Mar 23, 2022
Total Immunoglobulin E (IgE)
Immunology
61d
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