Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K904098 |
Device Name |
CEDIA TOTAL T3 ASSAY |
Applicant |
MICROGENICS CORP. |
2380A BISSO LN. |
CONCORD,
CA
94520
|
|
Applicant Contact |
Patricia M Klimley |
Correspondent |
MICROGENICS CORP. |
2380A BISSO LN. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
Patricia M Klimley |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 09/06/1990 |
Decision Date | 09/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|