← Product Code [DBA](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBA) · K780335

# LAS-R HUMAN C1 ESTERASE INHIBITOR TEST (K780335)

_Hyland Therapeutic Div., Travenol Laboratories · DBA · Mar 22, 1978 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBA/K780335

## Device Facts

- **Applicant:** Hyland Therapeutic Div., Travenol Laboratories
- **Product Code:** [DBA](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBA.md)
- **Decision Date:** Mar 22, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5250
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBA/K780335](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBA/K780335)

**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