Device Classification Name |
calibrator, secondary
|
510(k) Number |
K082141 |
Device Name |
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 |
Applicant |
BIOKIT S.A. |
CAN MALE S/N |
LLICA D'AMUNT |
BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
CAN MALE S/N |
LLICA D'AMUNT |
BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/30/2008 |
Decision Date | 09/03/2008 |
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
|
|
|