Device Classification Name |
method, nephelometric, immunoglobulins (g, a, m)
|
510(k) Number |
K073561 |
Device Name |
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR |
Applicant |
DADE BEHRING, INC. |
P.O BOX 6101, MS514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
HELEN M LEE |
Correspondent |
DADE BEHRING, INC. |
P.O BOX 6101, MS514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
HELEN M LEE |
Regulation Number | 866.5510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2007 |
Decision Date | 02/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|