Device Classification Name |
radioimmunoassay, total triiodothyronine
|
510(k) Number |
K852537 |
Device Name |
T-3 RIASSAY |
Applicant |
RIA DIAGNOSTICS |
8226 ALLPORT AVENEUE |
SANTA FE SPRINGS,
CA
90670
|
|
Applicant Contact |
GEORGE L BROUSSALIA |
Correspondent |
RIA DIAGNOSTICS |
8226 ALLPORT AVENEUE |
SANTA FE SPRINGS,
CA
90670
|
|
Correspondent Contact |
GEORGE L BROUSSALIA |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 06/14/1985 |
Decision Date | 08/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|