DFI · Total Spinal-Fluid, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5860 · Class 1
Overview
| Product Code | DFI |
|---|---|
| Device Name | Total Spinal-Fluid, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5860 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854190 | CANTROL SPINAL FLUID CONTROL | Canyon Diagnostics, Inc. | Nov 25, 1985 | SESE |
| K843122 | RESOLVE-CSF | Isolab, Inc. | Nov 30, 1984 | SESE |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | Somas Medical Industries, Inc. | Apr 5, 1984 | SESE |
| K832821 | FIAX IGG TEST | Intl. Diagnostic Technology | Oct 14, 1983 | SESE |
Top Applicants
- Canyon Diagnostics, Inc. — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Isolab, Inc. — 1 clearance
- Somas Medical Industries, Inc. — 1 clearance
