OYE · Class II · 21 CFR 864.5220

FDA Product Code OYE: Flow Cytometric Reagents And Accessories.

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.

Leading manufacturers include Beckman Coulter, Inc., Becton, Dickinson and Company and Bd Biosciences.

8
Total
8
Cleared
213d
Avg days
2013
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Flow Cytometric Reagents And Accessories. Devices (Product Code OYE)

8 devices
1–8 of 8
Cleared Nov 22, 2023
DxFLEX Flow Cytometer
K232600
Beckman Coulter, Inc.
Immunology · 86d
Cleared Sep 28, 2020
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
K201814
Becton, Dickinson and Company
Immunology · 89d
Cleared Jul 03, 2017
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
K170974
Becton, Dickinson and Company
Immunology · 91d
Cleared Jun 23, 2017
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
K162897
Beckman Coulter
Immunology · 249d
Cleared Apr 10, 2015
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
K141932
Beckman Coulter, Inc.
Immunology · 268d
Cleared Feb 27, 2015
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
K141468
Bd Biosciences
Immunology · 269d
Cleared Sep 18, 2013
NAVIOS FLOW CYTOMETER SYSTEM
K130373
Beckman Coulter, Inc.
Hematology · 216d
Cleared Jul 26, 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
K121445
Beckman Coulter, Inc.
Hematology · 437d

About Product Code OYE - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code OYE since 2013, with 8 receiving FDA clearance (average review time: 213 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.