Device Classification Name |
Flow Cytometric Reagents And Accessories.
|
510(k) Number |
K121445 |
Device Name |
TETRACHROME REAGENTS AND TETRACXP SYSTEM |
Applicant |
BECKMAN COULTER, INC. |
11800 SW 147TH AVE. |
M/S 31-B06 |
MIAMI,
FL
33196 -2500
|
|
Applicant Contact |
NANCY NADLER |
Correspondent |
BECKMAN COULTER, INC. |
11800 SW 147TH AVE. |
M/S 31-B06 |
MIAMI,
FL
33196 -2500
|
|
Correspondent Contact |
NANCY NADLER |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 05/15/2012 |
Decision Date | 07/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|