Device Classification Name |
enzyme immunoassay, digoxin
|
510(k) Number |
K033007 |
Device Name |
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM |
Applicant |
BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Applicant Contact |
KENNETH T EDDS |
Correspondent |
BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Correspondent Contact |
KENNETH T EDDS |
Regulation Number | 862.3320
|
Classification Product Code |
|
Date Received | 09/26/2003 |
Decision Date | 11/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|