|
Device |
flow cytometric reagents and accessories. |
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. |
Product Code | OYE |
Regulation Number |
864.5220
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BD BIOSCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECKMAN COULTER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. BK230961 Flow Cytometric Reagents and Accessories
|
2. K121445 TETRACHROME REAGENTS AND TETRACXP SYSTEM
|
3. K130373 NAVIOS FLOW CYTOMETER SYSTEM
|
4. K141932 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQU ...
|
BECKMAN COULTER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. BK230961 Flow Cytometric Reagents and Accessories
|
2. K121445 TETRACHROME REAGENTS AND TETRACXP SYSTEM
|
3. K130373 NAVIOS FLOW CYTOMETER SYSTEM
|
4. K141932 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQU ...
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
1. BK230961 Flow Cytometric Reagents and Accessories
|
2. K121445 TETRACHROME REAGENTS AND TETRACXP SYSTEM
|
3. K130373 NAVIOS FLOW CYTOMETER SYSTEM
|
4. K141932 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQU ...
|
BECTON, DICKINSON & COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|