DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
Device Facts
| Record ID | K904302 |
|---|---|
| Device Name | DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | DIC · Clinical Toxicology |
| Decision Date | Oct 12, 1990 |
| 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.
