Device Classification Name |
counter, differential cell
|
510(k) Number |
K990172 |
Device Name |
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA |
Applicant |
COULTER CORP. |
11800 S.W. 147TH AVE. |
MIAMI,
FL
33196 -2500
|
|
Applicant Contact |
MARION S GAIDE |
Correspondent |
COULTER CORP. |
11800 S.W. 147TH AVE. |
MIAMI,
FL
33196 -2500
|
|
Correspondent Contact |
MARION S GAIDE |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 01/19/1999 |
Decision Date | 04/13/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|