ELVI-AMINOLEVULINIC ACID
Device Facts
| Record ID | K792407 |
|---|---|
| Device Name | ELVI-AMINOLEVULINIC ACID |
| Applicant | Volu Sol Medical Industries |
| Product Code | DIJ · Clinical Toxicology |
| Decision Date | Jan 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3550 |
| Device Class | Class 2 |
Regulatory Classification
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.
