OYE

Flow Cytometric Reagents And Accessories.

Product code

OYE

Device name

Flow Cytometric Reagents And Accessories.

Device class

Class 2

21 CFR

21 CFR 864.5220

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-22.

1 summaries are archived here for direct download.