← Product Code [DEF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF) · K924186

# LPIA-FERRITIN ASSAY (K924186)

_Seradyn, Inc. · DEF · Dec 23, 1992 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF/K924186

## Device Facts

- **Applicant:** Seradyn, Inc.
- **Product Code:** [DEF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF.md)
- **Decision Date:** Dec 23, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5425
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF/K924186](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEF/K924186)

**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