Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
|
510(k) Number |
K081161 |
Device Name |
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST |
Applicant |
DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
HELEN M LEE |
Correspondent |
DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
HELEN M LEE |
Regulation Number | 866.5510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/24/2008 |
Decision Date | 07/28/2008 |
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
|
|
|