JIZ · Atomic Absorption, Iron (Non-Heme)
Clinical Chemistry · 21 CFR 862.1410 · Class 1
Overview
| Product Code | JIZ |
|---|---|
| Device Name | Atomic Absorption, Iron (Non-Heme) |
| Regulation | 21 CFR 862.1410 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
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.
Cleared Devices (0)
No cleared devices on record.
