21 CFR 862.1640 — Wet Ash Method, Protein-Bound Iodine
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1640
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JIJ | Wet Ash Method, Protein-Bound Iodine | 1 | 0 | |
| JIK | Dry Ash Method, Protein-Bound Iodine | 1 | 0 |
