EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
Device Facts
| Record ID | K010960 |
|---|---|
| Device Name | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | DIC · Clinical Toxicology |
| Decision Date | Apr 26, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
