Device Classification Name |
counter, differential cell
|
510(k) Number |
K053308 |
Device Name |
ABX MICROS CRP 200, OPTION IM |
Applicant |
HORIBA ABX |
PARC EUROMEDECINE |
RUE DU CADUCEE |
MONTPELLIER, HERAULT,
FR
34184
|
|
Applicant Contact |
TIM LAWTON |
Correspondent |
HORIBA ABX |
PARC EUROMEDECINE |
RUE DU CADUCEE |
MONTPELLIER, HERAULT,
FR
34184
|
|
Correspondent Contact |
TIM LAWTON |
Regulation Number | 864.5220
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/28/2005 |
Decision Date | 12/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|