← Product Code [DFI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFI) · K840974

# SOMAS HUMAN SPINAL FLUID CONTROL (K840974)

_Somas Medical Industries, Inc. · DFI · Apr 5, 1984 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFI/K840974

## Device Facts

- **Applicant:** Somas Medical Industries, Inc.
- **Product Code:** [DFI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFI.md)
- **Decision Date:** Apr 5, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5860
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFI/K840974](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFI/K840974)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
