ALBUMIN CAT. # 201-03
Device Facts
| Record ID | K875207 |
|---|---|
| Device Name | ALBUMIN CAT. # 201-03 |
| Applicant | Diagnostic Chemicals, Ltd. (Usa) |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Apr 18, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
