HEMATOLOGY ANALYZER
Device Facts
| Record ID | K842310 |
|---|---|
| Device Name | HEMATOLOGY ANALYZER |
| Applicant | Hml Inc/Biotechnology Transfer |
| Product Code | JKL · Clinical Chemistry |
| Decision Date | Sep 6, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1060 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).
