Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K080167 |
Device Name |
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
PHILIP LIU |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
PHILIP LIU |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 01/23/2008 |
Decision Date | 08/08/2008 |
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
|
|
|