← Product Code [JMO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO) · K912795

# BIOTROL UIBC REAGENT (K912795)

_Biotrol, USA, Inc. · JMO · Aug 12, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K912795

## Device Facts

- **Applicant:** Biotrol, USA, Inc.
- **Product Code:** [JMO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO.md)
- **Decision Date:** Aug 12, 1991
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K912795](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K912795)

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