STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
Device Facts
| Record ID | K870158 |
|---|---|
| Device Name | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. |
| Applicant | American Dade |
| Product Code | CEC · Clinical Chemistry |
| Decision Date | Mar 19, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1695 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
