Device Classification Name |
enzymatic method, creatinine
|
510(k) Number |
K110137 |
Device Name |
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN |
Applicant |
HORIBA ABX S.A.S. |
PARC EUROMEDECINE |
RUE DU CADUCEE-BP 7290 |
MONTPELLIER CEDEX 4, HERAULT,
FR
34184
|
|
Applicant Contact |
CAROLINE FERRER |
Correspondent |
HORIBA ABX S.A.S. |
PARC EUROMEDECINE |
RUE DU CADUCEE-BP 7290 |
MONTPELLIER CEDEX 4, HERAULT,
FR
34184
|
|
Correspondent Contact |
CAROLINE FERRER |
Regulation Number | 862.1225
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/18/2011 |
Decision Date | 08/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|