Device Classification Name |
mixture, hematology quality control
|
510(k) Number |
K061511 |
Device Name |
R&D CBC-3D + CRP HEMATOLOGY CONTROL |
Applicant |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
RALPH E HOGANCAMP |
Correspondent |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. |
MINNEAPOLIS,
MN
55413
|
|
Correspondent Contact |
RALPH E HOGANCAMP |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 06/01/2006 |
Decision Date | 07/10/2006 |
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
|
|
|