Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K060027 |
Device Name |
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) |
Applicant |
BIOKIT S.A. |
LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Applicant Contact |
JOAN GUIXER |
Correspondent |
BIOKIT S.A. |
LLISSA D'AMUNT |
BARCELONA,
ES
08186
|
|
Correspondent Contact |
JOAN GUIXER |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2006 |
Decision Date | 01/26/2006 |
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
|
|
|