Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K160757 |
Device Name |
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) |
Applicant |
AXIS-SHIELD DIAGNOSTICS LIMITED |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,
GB
DD2 1XA
|
|
Applicant Contact |
CLAIRE I. DORA |
Correspondent |
AXIS-SHIELD DIAGNOSTICS LIMITED |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,
GB
DD2 1XA
|
|
Correspondent Contact |
CLAIRE I. DORA |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/2016 |
Decision Date | 07/26/2016 |
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
|
|
|