Device Classification Name |
Radioimmunoassay, Thyroxine-Binding Globulin
|
510(k) Number |
K905777 |
Device Name |
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT |
Applicant |
IMMUNOTECH CORP. |
90 WINDOM STREET, PO BOX 860 |
BOSTON,
MA
02134
|
|
Applicant Contact |
FRANCIS CAPITANIO |
Correspondent |
IMMUNOTECH CORP. |
90 WINDOM STREET, PO BOX 860 |
BOSTON,
MA
02134
|
|
Correspondent Contact |
FRANCIS CAPITANIO |
Regulation Number | 862.1685
|
Classification Product Code |
|
Date Received | 12/27/1990 |
Decision Date | 01/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|