DMI · Potassium Dichromate Specific Reagent For Alcohol
Clinical Toxicology · 21 CFR 862.3040 · Class 2
Overview
| Product Code | DMI |
|---|---|
| Device Name | Potassium Dichromate Specific Reagent For Alcohol |
| Regulation | 21 CFR 862.3040 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903228 | EMIT ETS PLUS ETHYL ALCOHOL ASSAY | Syva Co. | Aug 17, 1990 | SESE |
Top Applicants
- Syva Co. — 1 clearance
