Device Classification Name |
counter, differential cell
|
510(k) Number |
K030144 |
Device Name |
MODIFICATION TO PENTRA 60 AND PENTRA 60C+ |
Applicant |
ABX DIAGNOSTICS |
PARC EUROMEDECINE |
RUE DU CADUCEE |
MONPELLIER,
FR
34184
|
|
Applicant Contact |
TIM LAWTON |
Correspondent |
ABX DIAGNOSTICS |
PARC EUROMEDECINE |
RUE DU CADUCEE |
MONPELLIER,
FR
34184
|
|
Correspondent Contact |
TIM LAWTON |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 01/15/2003 |
Decision Date | 01/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|