MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
Device Facts
| Record ID | K911634 |
|---|---|
| Device Name | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST |
| Applicant | Immunotech Corp. |
| Product Code | CEC · Clinical Chemistry |
| Decision Date | Jun 24, 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.
