DxFLEX Flow Cytometer; ClearLLab 10C Panels
FDA 510(k) K232600 · Beckman Coulter, Inc.
510(k) numberK232600
Submission
- Device name
- DxFLEX Flow Cytometer; ClearLLab 10C Panels
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- August 28, 2023
- Decision date
- November 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
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| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…OYE · Traditional | Beckman Coulter | 06/23/2017SE |
| K141932 | Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol…OYE · Traditional | Beckman Coulter, Inc. | 04/10/2015SE |
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Questions and answers
When was DxFLEX Flow Cytometer; ClearLLab 10C Panels cleared by the FDA?
DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600) received a 510(k) decision of Substantially Equivalent on November 22, 2023, 86 days after the submission was received.
What is the product code of K232600?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.