OYE · Class II · 21 CFR 864.5220

Flow Cytometric Reagents And Accessories. — FDA 510(k) Devices

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.

1
Total
1
Cleared
86d
Avg days
2023
Since

List of Flow Cytometric Reagents And Accessories. devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Flow Cytometric Reagents And Accessories. devices (product code OYE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Immunology FDA review panel. Browse all Immunology devices →