Device Classification Name |
Hexokinase, Glucose
|
510(k) Number |
K103788 |
Device Name |
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
Applicant |
HORIBA ABX SAS |
PARC EUROMEDECINE |
RUE DU CADUCEE - BP7290 |
MONTPELLIER,
FR
34184
|
|
Applicant Contact |
CAROLINE FERRER |
Correspondent |
HORIBA ABX SAS |
PARC EUROMEDECINE |
RUE DU CADUCEE - BP7290 |
MONTPELLIER,
FR
34184
|
|
Correspondent Contact |
CAROLINE FERRER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/2010 |
Decision Date | 11/08/2011 |
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
|
|
|