AMERLITE TT3 ASSAY, LAN.0003/1003/2003
Device Facts
| Record ID | K873858 |
|---|---|
| Device Name | AMERLITE TT3 ASSAY, LAN.0003/1003/2003 |
| Applicant | Amersham Corp. |
| Product Code | CDP · Clinical Chemistry |
| Decision Date | Nov 3, 1987 |
| 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.
