SOMAS HUMAN SPINAL FLUID CONTROL
Device Facts
| Record ID | K840974 |
|---|---|
| Device Name | SOMAS HUMAN SPINAL FLUID CONTROL |
| Applicant | Somas Medical Industries, Inc. |
| Product Code | DFI · Immunology |
| Decision Date | Apr 5, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5860 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteins may aid in the diagnosis of multiple sclerosis and other diseases of the nervous system.
