Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550) → DOX — Fluorometer, Lead (Dedicated Instruments)

# DOX · Fluorometer, Lead (Dedicated Instruments)

_Clinical Toxicology · 21 CFR 862.3550 · Class 2_

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

## Overview

- **Product Code:** DOX
- **Device Name:** Fluorometer, Lead (Dedicated Instruments)
- **Regulation:** [21 CFR 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K014195](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K014195.md) | KAYAK HYDROPHILIC GUIDE WIRES | Boston Scientific Corp | Mar 19, 2002 | SESE |
| [K944226](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K944226.md) | MSI PROCEDURE KIT | Msi, Inc. | Jun 21, 1995 | SESE |
| [K900822](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K900822.md) | HYDRO-SIL(TM) COATED GUIDEWIRES | National-Standard Medical Products | Jul 17, 1990 | SESE |
| [K832030](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOX/K832030.md) | HEPARIN COATED STAINLESS STEEL/TEFLON | Argon Medical Corp. | Sep 29, 1983 | SESE |

## Top Applicants

- Argon Medical Corp. — 1 clearance
- Boston Scientific Corp — 1 clearance
- Msi, Inc. — 1 clearance
- National-Standard Medical Products — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com