Device Classification Name |
alpha-1-antitrypsin, antigen, antiserum, control
|
510(k) Number |
K050596 |
Device Name |
QUANTIA A1-AT |
Applicant |
BIOKIT S.A. |
LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 866.5130
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/08/2005 |
Decision Date | 05/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|