Device Classification Name |
antinuclear antibody (enzyme-labeled), antigen, controls
|
510(k) Number |
K131185 |
Device Name |
ANA SCREEN ELISA (IGG) |
Applicant |
EUROIMMUN US |
1100 THE AMERICAN ROAD |
MORRIS PLAINS,
NJ
07950
|
|
Applicant Contact |
MICHAEL LOCKE |
Correspondent |
EUROIMMUN US |
1100 THE AMERICAN ROAD |
MORRIS PLAINS,
NJ
07950
|
|
Correspondent Contact |
MICHAEL LOCKE |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 04/26/2013 |
Decision Date | 07/15/2013 |
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
|
|
|