SANDARE IRON-BINDING CAPACITY PROCEDURE
Device Facts
| Record ID | K851395 |
|---|---|
| Device Name | SANDARE IRON-BINDING CAPACITY PROCEDURE |
| Applicant | Sandare Chemical Co., Inc. |
| Product Code | JMO · Clinical Chemistry |
| Decision Date | May 7, 1985 |
| 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.
