Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K955097 |
Device Name |
AMERLITE MAB FT4 ASSAY |
Applicant |
KODAK CLINICAL DIAGNOSTICS, LTD. |
NIGHTINGALES LANE |
CHALFONT ST GILES |
BUCKINGHAMSHIRE,
GB
HP84SP
|
|
Applicant Contact |
SARAH CLARK |
Correspondent |
KODAK CLINICAL DIAGNOSTICS, LTD. |
NIGHTINGALES LANE |
CHALFONT ST GILES |
BUCKINGHAMSHIRE,
GB
HP84SP
|
|
Correspondent Contact |
SARAH CLARK |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/07/1995 |
Decision Date | 12/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|