DOX · Fluorometer, Lead (Dedicated Instruments)
Clinical Toxicology · 21 CFR 862.3550 · Class 2
Overview
| Product Code | DOX |
|---|---|
| Device Name | Fluorometer, Lead (Dedicated Instruments) |
| Regulation | 21 CFR 862.3550 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
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 | KAYAK HYDROPHILIC GUIDE WIRES | Boston Scientific Corp | Mar 19, 2002 | SESE |
| K944226 | MSI PROCEDURE KIT | Msi, Inc. | Jun 21, 1995 | SESE |
| K900822 | HYDRO-SIL(TM) COATED GUIDEWIRES | National-Standard Medical Products | Jul 17, 1990 | SESE |
| K832030 | 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
