Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K121951 |
Device Name |
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 |
Applicant |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Applicant Contact |
KELLY R SAUER |
Correspondent |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Correspondent Contact |
KELLY R SAUER |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/03/2012 |
Decision Date | 04/04/2013 |
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
|
|
|