EMDS(TM) ALCOHOL TESTPACKS, #67691/95
Device Facts
| Record ID | K863419 |
|---|---|
| Device Name | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | DML · Clinical Toxicology |
| Decision Date | Sep 29, 1986 |
| 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.
