Device Classification Name |
System, Test, Vitamin D
|
510(k) Number |
K110619 |
Device Name |
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS |
Applicant |
BIOKIT S.A. |
CAN MALE, S/N |
LLISSA D'AMUNT, BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
CAN MALE, S/N |
LLISSA D'AMUNT, BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 862.1825
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/03/2011 |
Decision Date | 11/23/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|