JIK · Dry Ash Method, Protein-Bound Iodine
Clinical Chemistry · 21 CFR 862.1640 · Class 1
Overview
| Product Code | JIK |
|---|---|
| Device Name | Dry Ash Method, Protein-Bound Iodine |
| Regulation | 21 CFR 862.1640 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
