Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K110579 |
Device Name |
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT 9V6, AP5N-2 |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
DARLA ABANO |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD |
DEPT 9V6, AP5N-2 |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
DARLA ABANO |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/01/2011 |
Decision Date | 10/06/2011 |
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
|
|
|