← Product Code [DFK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFK) · K770670

# FLOR. CONJUG. HUMAN FAB FRAGMENT (K770670)

_Kent Laboratories, Inc. · DFK · Apr 28, 1977 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFK/K770670

## Device Facts

- **Applicant:** Kent Laboratories, Inc.
- **Product Code:** [DFK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFK.md)
- **Decision Date:** Apr 28, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5520
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFK/K770670](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFK/K770670)

**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