Device Classification Name |
radioimmunoassay, total triiodothyronine
|
510(k) Number |
K894993 |
Device Name |
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 520672 |
MIAMI,
FL
33152
|
|
Applicant Contact |
NANCY A HORNBAKER |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 520672 |
MIAMI,
FL
33152
|
|
Correspondent Contact |
NANCY A HORNBAKER |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 08/08/1989 |
Decision Date | 10/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|