PSI ALBUMIN REAGENT
Device Facts
| Record ID | K822471 |
|---|---|
| Device Name | PSI ALBUMIN REAGENT |
| Applicant | Pointe Scientific, Inc., |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Sep 14, 1982 |
| 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.
