Device Classification Name |
Apparatus, Automated Blood Cell Diluting
|
510(k) Number |
K100684 |
Device Name |
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 |
Applicant |
VERIDEX, LLC |
1001 US HIGHWAY 202 NORTH |
RARITAN,
NJ
08869 -0606
|
|
Applicant Contact |
SARAH MCMANUS |
Correspondent |
VERIDEX, LLC |
1001 US HIGHWAY 202 NORTH |
RARITAN,
NJ
08869 -0606
|
|
Correspondent Contact |
SARAH MCMANUS |
Regulation Number | 864.5240
|
Classification Product Code |
|
Date Received | 03/10/2010 |
Decision Date | 08/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|