Device Classification Name |
Calibrator, Primary
|
510(k) Number |
K053104 |
Device Name |
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101 BUILDING 500 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
ANDREA M TASKER |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101 BUILDING 500 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
ANDREA M TASKER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/04/2005 |
Decision Date | 12/23/2005 |
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
|
|
|