← Product Code [DAK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK) · K882829

# CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829)

_Cytotech, Inc. · DAK · Aug 4, 1988 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K882829

## Device Facts

- **Applicant:** Cytotech, Inc.
- **Product Code:** [DAK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK.md)
- **Decision Date:** Aug 4, 1988
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K882829](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K882829)

**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