← Product Code [DOX](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX) · K900822

# HYDRO-SIL(TM) COATED GUIDEWIRES (K900822)

_National-Standard Medical Products · DOX · Jul 17, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K900822

## Device Facts

- **Applicant:** National-Standard Medical Products
- **Product Code:** [DOX](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX.md)
- **Decision Date:** Jul 17, 1990
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K900822](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K900822)

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