Device Classification Name |
calibrator, secondary
|
510(k) Number |
K132400 |
Device Name |
LP(A) CALIBRATORS, AND LP(A) CONTROLS |
Applicant |
BIOKIT S.A. |
CAN MALE, S/N |
LLISSA D'AMUNT, BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
CAN MALE, S/N |
LLISSA D'AMUNT, BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2013 |
Decision Date | 12/19/2013 |
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
|
|
|