← Product Code [CFM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM) · K895047

# CLINISTAT POTASSIUM REAGENT TEST (K895047)

_Heraeus Kulzer, Inc. · CFM · Oct 17, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K895047

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [CFM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM.md)
- **Decision Date:** Oct 17, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1410
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K895047](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K895047)

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