Device Classification Name |
lipoprotein, low-density, antigen, antiserum, control
|
510(k) Number |
K050487 |
Device Name |
QUANTIA LA(A) |
Applicant |
BIOKIT S.A. |
CAN MALE LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
CAN MALE LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 866.5600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/25/2005 |
Decision Date | 04/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|