DML · Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Clinical Toxicology · 21 CFR 862.3040 · Class 2
Overview
| Product Code | DML |
|---|---|
| Device Name | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method |
| 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013538 | ETHANOL | Abbott Laboratories | Dec 14, 2001 | SESE |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Syva Co. | Feb 1, 2000 | SESE |
| K963197 | ON.SITE ALCOHOL | Ansys, Inc. | Sep 19, 1996 | SESE |
| K953765 | AXSYM REA ETHANOL | Abbott Laboratories | Sep 27, 1995 | SESE |
| K952839 | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY | Boehringer Mannheim Corp. | Aug 24, 1995 | SESE |
| K923337 | ON*SITE ALCOHOL | Toxi-Lab, Inc. | Jan 12, 1993 | SESE |
| K914777 | SIGMA PROCEDURE NO. 333-UV | Sigma Diagnostics, Inc. | Dec 27, 1991 | SESE |
| K874382 | RAICHEM(TM) ALCOHOL REAGENT | Reagents Applications, Inc. | Jan 11, 1988 | SESE |
| K872180 | KINETIC 610 ETHANOL | American Monitor Corp. | Jul 7, 1987 | SESE |
| K863419 | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 | Em Diagnostic Systems, Inc. | Sep 29, 1986 | SESE |
| K840769 | PARAMAX ALCOHOL REAGENT | American Dade | Apr 13, 1984 | SESE |
| K840400 | EMIT ST SERUM ETHYL ALCOHOL ASSAY | Syva Co. | Mar 23, 1984 | SESE |
| K840171 | EMIT ST URINE ETHYL ALCOHOL ASSAY | Syva Co. | Mar 19, 1984 | SESE |
Top Applicants
- Syva Co. — 3 clearances
- Abbott Laboratories — 2 clearances
- American Dade — 1 clearance
- American Monitor Corp. — 1 clearance
- Ansys, Inc. — 1 clearance
