Device Classification Name |
Mixture, Hematology Quality Control
|
510(k) Number |
K010409 |
Device Name |
CBC-SF |
Applicant |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
KENNETH T EDDS |
Correspondent |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Correspondent Contact |
KENNETH T EDDS |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 03/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|