← Product Code [JMO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO) · K832759

# TOTAL IRON-BINDING CAPACITY ACCESORY (K832759)

_Seragen Diagnostics, Inc. · JMO · Oct 14, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K832759

## Device Facts

- **Applicant:** Seragen Diagnostics, Inc.
- **Product Code:** [JMO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO.md)
- **Decision Date:** Oct 14, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1415
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K832759](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K832759)

**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