HUMAN IGG-ALBUMIN TEST KIT
Device Facts
| Record ID | K811178 |
|---|---|
| Device Name | HUMAN IGG-ALBUMIN TEST KIT |
| Applicant | Meloy Laboratories, Inc. |
| Product Code | CJQ · Clinical Chemistry |
| Decision Date | May 15, 1981 |
| 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.
