INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
Device Facts
| Record ID | K792469 |
|---|---|
| Device Name | INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS |
| Applicant | Intersci Corp. |
| Product Code | DOJ · Clinical Toxicology |
| Decision Date | Jan 23, 1980 |
| 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.
