← Product Code [DOF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF) · K843839

# STAT/PB REAGENT (K843839)

_Tri-Tech, Inc. · DOF · Jan 3, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K843839

## Device Facts

- **Applicant:** Tri-Tech, Inc.
- **Product Code:** [DOF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF.md)
- **Decision Date:** Jan 3, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3550
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K843839](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K843839)

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