COBAS STANDARDS FOR ALBUMIN
Device Facts
| Record ID | K823575 |
|---|---|
| Device Name | COBAS STANDARDS FOR ALBUMIN |
| Applicant | Hoffmann-La Roche, Inc. |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Jan 7, 1983 |
| 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.
