Device Classification Name |
radioimmunoassay, total thyroxine
|
510(k) Number |
K911985 |
Device Name |
LUMATAG T4 CHEMILUMINESCENCE ASSAY |
Applicant |
LONDON DIAGNOSTICS, INC. |
10300 VALLEY VIEW RD. |
SUITE 107 |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
RAMAKRISHNAN |
Correspondent |
LONDON DIAGNOSTICS, INC. |
10300 VALLEY VIEW RD. |
SUITE 107 |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
RAMAKRISHNAN |
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 05/06/1991 |
Decision Date | 08/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|