← Product Code [DAY](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY) · K950102

# HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (K950102)

_Kent Laboratories, Inc. · DAY · Apr 10, 1995 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K950102

## Device Facts

- **Applicant:** Kent Laboratories, Inc.
- **Product Code:** [DAY](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY.md)
- **Decision Date:** Apr 10, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5240
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K950102](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K950102)

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