Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K121946 |
Device Name |
AXIS-SHIELD ACVTIVE-B12 |
Applicant |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK, LUNA PLACE |
DUNDEE, SCOTLAND,
GB
DD2 1XA
|
|
Applicant Contact |
SIMON JOHN RICHARDS |
Correspondent |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK, LUNA PLACE |
DUNDEE, SCOTLAND,
GB
DD2 1XA
|
|
Correspondent Contact |
SIMON JOHN RICHARDS |
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 07/03/2012 |
Decision Date | 03/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|