DART IRON & IRON BINDING CAPACITY REAGENT
Device Facts
| Record ID | K854305 |
|---|---|
| Device Name | DART IRON & IRON BINDING CAPACITY REAGENT |
| Applicant | Coulter Electronics, Inc. |
| Product Code | CFM · Clinical Chemistry |
| Decision Date | Nov 12, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1410 |
| Device Class | Class 1 |
Regulatory Classification
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.
