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..

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

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.

OYE devices are reviewed by the Immunology panel. Browse all Immunology devices →