Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K070146 |
Device Name |
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP |
Applicant |
HORIBA ABX |
PARC EUROMEDECINE |
RUE DU CADUCEE, BP 7290 |
MONTPELLIER,
FR
34184
|
|
Applicant Contact |
PASCAL MACZIOLA |
Correspondent |
HORIBA ABX |
PARC EUROMEDECINE |
RUE DU CADUCEE, BP 7290 |
MONTPELLIER,
FR
34184
|
|
Correspondent Contact |
PASCAL MACZIOLA |
Regulation Number | 862.1770
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/16/2007 |
Decision Date | 10/12/2007 |
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
|
|
|