Device Classification Name |
system, test, rheumatoid factor
|
510(k) Number |
K160070 |
Device Name |
Rheumatoid Factor (RF) Kit for use on SPAPLUS |
Applicant |
THE BINDING SITE GROUP, LTD. |
8 CALTHORPE ROAD |
EDGBASTON,
GB
B15 1QT
|
|
Applicant Contact |
Jon Lauder |
Correspondent |
THE BINDING SITE GROUP, LTD. |
8 CALTHORPE ROAD |
EDGBASTON,
GB
B15 1QT
|
|
Correspondent Contact |
Jon Lauder |
Regulation Number | 866.5775
|
Classification Product Code |
|
Date Received | 01/13/2016 |
Decision Date | 12/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|