EMIT ST SERUM ETHYL ALCOHOL ASSAY
Device Facts
| Record ID | K840400 |
|---|---|
| Device Name | EMIT ST SERUM ETHYL ALCOHOL ASSAY |
| Applicant | Syva Co. |
| Product Code | DML · Clinical Toxicology |
| Decision Date | Mar 23, 1984 |
| 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.
