← Product Code [JZR](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZR) · K831603

# TITAN GE/IEPLATE (K831603)

_Helena Laboratories · JZR · Jul 7, 1983 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZR/K831603

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JZR](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZR.md)
- **Decision Date:** Jul 7, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4900
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZR/K831603](https://fda.innolitics.com/submissions/CH/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZR/K831603)

**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