SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
Device Facts
| Record ID | K000410 |
|---|---|
| Device Name | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
| Applicant | Beckman Coulter, Inc. |
| Product Code | DMT · Clinical Toxicology |
| Decision Date | Apr 10, 2000 |
| 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.
