FDA 510(k)

DxFLEX Flow Cytometer; ClearLLab 10C Panels

Número K: K232600 · 2023-11-22

Data da decisão2023-11-22

Código do produtoOYE

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DxFLEX Flow Cytometer; ClearLLab 10C Panels is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K232600. The device is classified under product code OYE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DxFLEX Flow Cytometer; ClearLLab 10C Panels?

DxFLEX Flow Cytometer; ClearLLab 10C Panels is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K232600.

When did DxFLEX Flow Cytometer; ClearLLab 10C Panels receive FDA 510(k) clearance?

DxFLEX Flow Cytometer; ClearLLab 10C Panels received FDA 510(k) clearance on 2023-11-22, under 510(k) number K232600.

Who is the listed applicant for DxFLEX Flow Cytometer; ClearLLab 10C Panels?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DxFLEX Flow Cytometer; ClearLLab 10C Panels?

The FDA product code for DxFLEX Flow Cytometer; ClearLLab 10C Panels is OYE.

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Dispositivos Relacionados (Código: OYE)

K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color KitBecton, Dickinson and Company K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 LaserBeckman Coulter

Fonte oficial

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