Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K931600 |
Device Name |
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY |
Applicant |
NICHOLS INSTITUTE |
33608 ORTEGA HIGHWAY |
SAN JUAN CAPISTRANO,
CA
92690
|
|
Applicant Contact |
SALVADORE PALOMARES |
Correspondent |
NICHOLS INSTITUTE |
33608 ORTEGA HIGHWAY |
SAN JUAN CAPISTRANO,
CA
92690
|
|
Correspondent Contact |
SALVADORE PALOMARES |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 04/01/1993 |
Decision Date | 09/08/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|