Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K961236 |
Device Name |
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE |
Applicant |
UNITED BIOTECH, INC. |
110 PIONEER WAY, #C |
MOUNTAIN VIEW,
CA
94041 -1517
|
|
Applicant Contact |
WUAN T LU |
Correspondent |
UNITED BIOTECH, INC. |
110 PIONEER WAY, #C |
MOUNTAIN VIEW,
CA
94041 -1517
|
|
Correspondent Contact |
WUAN T LU |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 03/29/1996 |
Decision Date | 05/30/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|