Device Classification Name |
Mixture, Hematology Quality Control
|
510(k) Number |
K024173 |
Device Name |
CDS 3-PD HEMATOLOGY CONTROLS |
Applicant |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
1660 N.W. 65TH AVE., SUITE 2 |
PLANTATION,
FL
33313
|
|
Applicant Contact |
ANDREW C SWANSON |
Correspondent |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
1660 N.W. 65TH AVE., SUITE 2 |
PLANTATION,
FL
33313
|
|
Correspondent Contact |
ANDREW C SWANSON |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 12/18/2002 |
Decision Date | 01/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|