Flow Cytometric Reagents And Accessories.
The Flow Cytometric Reagents and Accessories device encompasses reagents and accessories used to identify and classify cells or other particles in suspension by their physical properties or associated fluorescent molecules, providing information about the distribution, number, or protein expression of cells in suspension, aiding in the diagnosis of conditions such as immunodeficiency and cancer. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OYE, with regulation number 864.5220 under the Hematology medical specialty.
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Basic Information
- Product Code
- OYE
- Device Class
- FDA class 2
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Nov 22, 2023 | Substantially Equivalent | Beckman Coulter, Inc. |
| K201814 | BD 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 Kit | Sep 28, 2020 | Substantially Equivalent | Becton, Dickinson and Company |
| K170974 | BD 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 TBNK | Jul 03, 2017 | Substantially Equivalent | Becton, Dickinson and Company |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | Jun 23, 2017 | Substantially Equivalent | Beckman Coulter |
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | Apr 10, 2015 | Substantially Equivalent | Beckman Coulter, Inc. |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | Feb 27, 2015 | Substantially Equivalent | Bd Biosciences |
| K130373 | NAVIOS FLOW CYTOMETER SYSTEM | Sep 18, 2013 | Substantially Equivalent | Beckman Coulter, Inc. |
| K121445 | TETRACHROME REAGENTS AND TETRACXP SYSTEM | Jul 26, 2013 | Substantially Equivalent | Beckman Coulter, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.