BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
Device Facts
| Record ID | K952839 |
|---|---|
| Device Name | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | DML · Clinical Toxicology |
| Decision Date | Aug 24, 1995 |
| 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.
