Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K952557 |
Device Name |
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS |
Applicant |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS,
MO
63103
|
|
Applicant Contact |
HOYLE D HILL |
Correspondent |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS,
MO
63103
|
|
Correspondent Contact |
HOYLE D HILL |
Regulation Number | 862.1710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/02/1995 |
Decision Date | 01/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|