DIRECT TIBC KIT
Device Facts
| Record ID | K000781 |
|---|---|
| Device Name | DIRECT TIBC KIT |
| Applicant | Reference Diagnostics, Inc. |
| Product Code | JMO · Clinical Chemistry |
| Decision Date | May 2, 2000 |
| 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.
