Device Classification Name |
radioimmunoassay, total triiodothyronine
|
510(k) Number |
K880388 |
Device Name |
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE |
Applicant |
SERONO DIAGNOSTICS, INC. |
100 LONGWATER CIRCLE |
NORWELL,
MA
02061
|
|
Applicant Contact |
PHILIP M FANTASIA |
Correspondent |
SERONO DIAGNOSTICS, INC. |
100 LONGWATER CIRCLE |
NORWELL,
MA
02061
|
|
Correspondent Contact |
PHILIP M FANTASIA |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 01/28/1988 |
Decision Date | 03/03/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|