Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K053020 |
Device Name |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
Applicant |
BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
ANDRES HOLLE |
Correspondent |
BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
ANDRES HOLLE |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/26/2005 |
Decision Date | 12/30/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|