← Product Code [JKJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKJ) · K893038

# PROTOFLUOR Z (K893038)

_Helena Laboratories · JKJ · Nov 17, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKJ/K893038

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JKJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKJ.md)
- **Decision Date:** Nov 17, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1595
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKJ/K893038](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKJ/K893038)

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