FDA 510(k) Applications Submitted by Beckman Coulter, Inc
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220972 |
04/04/2022 |
Access Thyroglobulin |
Beckman Coulter, Inc |
| K223921 |
12/29/2022 |
Access CEA |
Beckman Coulter, Inc |
| K130122 |
01/17/2013 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER |
BECKMAN COULTER, INC |
| K120199 |
01/23/2012 |
GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY |
BECKMAN COULTER, INC |
| K241427 |
05/20/2024 |
Access Syphilis |
Beckman Coulter, Inc |
| K193536 |
12/20/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8╡g/mL) |
Beckman Coulter, Inc |
| K231832 |
06/22/2023 |
Access Myoglobin |
Beckman Coulter, Inc |
| K221990 |
07/06/2022 |
Access Total ▀hCG (5th IS) |
Beckman Coulter, Inc |
| K234052 |
12/21/2023 |
Access Ferritin |
Beckman Coulter, Inc |
| K240479 |
02/20/2024 |
Access OV Monitor |
Beckman Coulter, Inc |
| K223038 |
09/29/2022 |
Access Cortisol |
Beckman Coulter, Inc |
| K240252 |
01/30/2024 |
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System |
Beckman Coulter, Inc |
| K240273 |
01/31/2024 |
Access Free T4 |
Beckman Coulter, Inc |
| K240927 |
04/04/2024 |
Access Thyroglobulin |
Beckman Coulter, Inc |
| K241423 |
05/20/2024 |
Access Thyroglobulin |
Beckman Coulter, Inc |
| K222996 |
09/28/2022 |
Access PCT |
Beckman Coulter, Inc |
| K234005 |
12/19/2023 |
Access CK-MB |
Beckman Coulter, Inc |
| K172255 |
07/26/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) |
Beckman Coulter, Inc |
| K232600 |
08/28/2023 |
DxFLEX Flow Cytometer; ClearLLab 10C Panels |
Beckman Coulter, Inc |
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