LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
Device Facts
| Record ID | K914835 |
|---|---|
| Device Name | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY |
| Applicant | London Diagnostics, Inc. |
| Product Code | CEC · Clinical Chemistry |
| Decision Date | Dec 17, 1991 |
| 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.
