Device Classification Name |
kappa, antigen, antiserum, control
|
510(k) Number |
K173732 |
Device Name |
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit |
Applicant |
The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston |
Birmingham,
GB
B15 1QT
|
|
Applicant Contact |
Christopher Bradshaw |
Correspondent |
The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston |
Birmingham,
GB
B15 1QT
|
|
Correspondent Contact |
Andrea Thomas |
Regulation Number | 866.5550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/06/2017 |
Decision Date | 08/23/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|