Device Classification Name |
Radioimmunoassay, Thyroxine-Binding Globulin
|
510(k) Number |
K884201 |
Device Name |
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT |
Applicant |
CYBERFLUOR, INC. |
179 JOHN ST., 4TH FL., |
TORONTO |
ONTARIO M5T 1X4,
CA
|
|
Applicant Contact |
JAMES CLELLAND |
Correspondent |
CYBERFLUOR, INC. |
179 JOHN ST., 4TH FL., |
TORONTO |
ONTARIO M5T 1X4,
CA
|
|
Correspondent Contact |
JAMES CLELLAND |
Regulation Number | 862.1685
|
Classification Product Code |
|
Date Received | 10/06/1988 |
Decision Date | 12/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|