FERRO-QUANT TM FE 59 TEST KIT
Device Facts
| Record ID | K800868 |
|---|---|
| Device Name | FERRO-QUANT TM FE 59 TEST KIT |
| Applicant | Mallinckrodt Critical Care |
| Product Code | JQG · Clinical Chemistry |
| Decision Date | Apr 29, 1980 |
| 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.