Device Classification Name |
Hexokinase, Glucose
|
510(k) Number |
K052007 |
Device Name |
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
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 | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/25/2005 |
Decision Date | 12/16/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|