IRON BINDING CAPACITY CHEMISTRY
Device Facts
| Record ID | K780094 |
|---|---|
| Device Name | IRON BINDING CAPACITY CHEMISTRY |
| Applicant | Harleco |
| Product Code | JMO · Clinical Chemistry |
| Decision Date | Feb 13, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1415 |
| Device Class | Class 1 |
Regulatory Classification
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.