ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
Device Facts
| Record ID | K001286 |
|---|---|
| Device Name | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | DIC · Clinical Toxicology |
| Decision Date | Jun 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3040 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
