DOF · Lead, Atomic Absorption
Clinical Toxicology · 21 CFR 862.3550 · Class 2
Overview
| Product Code | DOF |
|---|---|
| Device Name | Lead, Atomic Absorption |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | Jul 7, 2015 | SESE |
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Magellan Diagnostics | Aug 20, 2013 | SESE |
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | Esa Biosciences, Inc. | Oct 6, 2005 | SESE |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | Esa, Inc. | Sep 9, 1997 | SESE |
| K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION | Thermo Jarrell Ash Corp.Div.Thermo Inst. | Sep 6, 1994 | SESE |
| K843839 | STAT/PB REAGENT | Tri-Tech, Inc. | Jan 3, 1985 | SESE |
Top Applicants
- Magellan Diagnostics — 2 clearances
- Esa Biosciences, Inc. — 1 clearance
- Esa, Inc. — 1 clearance
- Thermo Jarrell Ash Corp.Div.Thermo Inst. — 1 clearance
- Tri-Tech, Inc. — 1 clearance
