DMT · Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Clinical Toxicology · 21 CFR 862.3040 · Class 2
Overview
| Product Code | DMT |
|---|---|
| Device Name | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | Beckman Coulter, Inc. | Apr 10, 2000 | SESE |
| K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | Beckman Instruments, Inc. | Jun 3, 1997 | SESE |
| K934273 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | Eastman Kodak Company | Mar 21, 1994 | SESE |
| K923783 | ETHYL ALCOHOL ASSAY | Diagnostic Reagents, Inc. | Jan 21, 1993 | SESE |
| K864894 | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | Em Diagnostic Systems, Inc. | Jan 9, 1987 | SESE |
| K843378 | ETHYL ALCOHOL ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Sep 14, 1984 | SESE |
| K810467 | EMIT-ST SERUM ETHYL ALCOHOL ASSAY | Syva Co. | Mar 6, 1981 | SESE |
| K802621 | EMIT-STM ETHYL ALCOHOL ASSAY | Syva Co. | Oct 31, 1980 | SESE |
Top Applicants
- Syva Co. — 2 clearances
- Beckman Coulter, Inc. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Diagnostic Chemicals, Ltd. (Usa) — 1 clearance
- Diagnostic Reagents, Inc. — 1 clearance
