Device Classification Name |
azo dye, calcium
|
510(k) Number |
K123171 |
Device Name |
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
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 | 862.1145
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/09/2012 |
Decision Date | 07/03/2013 |
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
|
|
|