Device Classification Name |
Counter, Differential Cell
|
510(k) Number |
K061616 |
Device Name |
COULTER LH 780 HEMATOLOGY ANALYZER |
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 | 06/08/2006 |
Decision Date | 10/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|