DIJ · Lead, Delta Amino Levulinic Acid
Clinical Toxicology · 21 CFR 862.3550 · Class 2
Overview
| Product Code | DIJ |
|---|---|
| Device Name | Lead, Delta Amino Levulinic Acid |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030826 | PRECISET DAT AMPHETAMINE | Quantimetrix Corp. | Apr 3, 2003 | SESE |
| K792407 | ELVI-AMINOLEVULINIC ACID | Volu Sol Medical Industries | Jan 16, 1980 | SESE |
Top Applicants
- Quantimetrix Corp. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
