Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K063508 |
Device Name |
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN |
Applicant |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,,
DE
19714
|
|
Applicant Contact |
HELEN M LEE |
Correspondent |
DADE BEHRING, INC. |
P.O. BOX 6101 |
NEWARK,,
DE
19714
|
|
Correspondent Contact |
HELEN M LEE |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/20/2006 |
Decision Date | 01/23/2007 |
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
|
|
|