Device Classification Name |
counter, differential cell
|
510(k) Number |
K072869 |
Device Name |
POINTCARE NOW SYSTEM |
Applicant |
POINTCARE TECHNOLOGIES INC. |
181 CEDAR HILL ST. |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
MAURICE N DOIRE |
Correspondent |
POINTCARE TECHNOLOGIES INC. |
181 CEDAR HILL ST. |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
MAURICE N DOIRE |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 10/09/2007 |
Decision Date | 01/14/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|