Device Classification Name |
System, Test, Carcinoembryonic Antigen
|
510(k) Number |
K071603 |
Device Name |
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) |
Applicant |
DADE BEHRING, INC. |
GLASGOW SITE, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
KATHLEEN DRAY-LYONS |
Correspondent |
DADE BEHRING, INC. |
GLASGOW SITE, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
KATHLEEN DRAY-LYONS |
Regulation Number | 866.6010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/12/2007 |
Decision Date | 06/25/2008 |
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
|
|
|