JQD · Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
Clinical Chemistry · 21 CFR 862.1415 · Class 1
Overview
| Product Code | JQD |
|---|---|
| Device Name | Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity |
| Regulation | 21 CFR 862.1415 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
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.
