SANDARE BCG ALBUMIN PROCEDURE
Device Facts
| Record ID | K860684 |
|---|---|
| Device Name | SANDARE BCG ALBUMIN PROCEDURE |
| Applicant | Sandare Chemical Co., Inc. |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Mar 17, 1986 |
| 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.
