Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K802883 |
Device Name |
T3-SQUIBB RIA KIT |
Applicant |
E. R. SQUIBB & SONS, INC. |
GEORGES RD. |
NEW BRUNSWICK,
NJ
|
|
Correspondent |
E. R. SQUIBB & SONS, INC. |
GEORGES RD. |
NEW BRUNSWICK,
NJ
|
|
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 11/17/1980 |
Decision Date | 12/19/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|