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FDA 510(k)

DxFLEX Flow Cytometer; ClearLLab 10C Panels

K-Number: K232600 · 2023-11-22

ApplicantBeckman Coulter, Inc.
Decision Date2023-11-22
Product CodeOYE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K232600.

When was DxFLEX Flow Cytometer; ClearLLab 10C Panels approved by the FDA?

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

What company makes DxFLEX Flow Cytometer; ClearLLab 10C Panels?

DxFLEX Flow Cytometer; ClearLLab 10C Panels is manufactured by Beckman Coulter, Inc..

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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Related Devices (Code: OYE)

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 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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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