Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K112443 |
Device Name |
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) |
Applicant |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,,
GB
DD2 1XA
|
|
Applicant Contact |
CLAIRE I DORA |
Correspondent |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,,
GB
DD2 1XA
|
|
Correspondent Contact |
CLAIRE I DORA |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/24/2011 |
Decision Date | 12/19/2011 |
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
|
|
|