Device Classification Name |
alpha-2-macroglobulin, antigen, antiserum, control
|
510(k) Number |
K081249 |
Device Name |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
Applicant |
DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
ANNA MARIE KATHLEEN ENNIS |
Correspondent |
DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
ANNA MARIE KATHLEEN ENNIS |
Regulation Number | 866.5620
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2008 |
Decision Date | 07/21/2008 |
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
|
|
|