Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K121314 |
Device Name |
ARCHITECT B12 |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT. 09V6 AP5 NORTH |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
DARLA A ABANO |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT. 09V6 AP5 NORTH |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
DARLA A ABANO |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2012 |
Decision Date | 05/17/2012 |
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
|
|
|