IMX T3 ASSAY
Device Facts
| Record ID | K944808 |
|---|---|
| Device Name | IMX T3 ASSAY |
| Applicant | Organon Teknika Corp. |
| Product Code | CDP · Clinical Chemistry |
| Decision Date | Dec 9, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
