Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
The Enzymatic Method using Alcohol Dehydrogenase with Ultraviolet detection is a laboratory system that measures ethyl alcohol in patient specimens by coupling the alcohol dehydrogenase enzymatic reaction with UV spectrophotometric detection of NADH formation. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DMT, regulated under 21 CFR 862.3040, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DMT
- Device Class
- FDA class 2
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | Apr 10, 2000 | Substantially Equivalent | Beckman Coulter, Inc. |
| K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | Jun 03, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K934273 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | Mar 21, 1994 | Substantially Equivalent | Eastman Kodak Company |
| K923783 | ETHYL ALCOHOL ASSAY | Jan 21, 1993 | Substantially Equivalent | Diagnostic Reagents, Inc. |
| K864894 | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | Jan 09, 1987 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K843378 | ETHYL ALCOHOL ASSAY KIT | Sep 14, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K810467 | EMIT-ST SERUM ETHYL ALCOHOL ASSAY | Mar 06, 1981 | Substantially Equivalent | Syva Co. |
| K802621 | EMIT-STM ETHYL ALCOHOL ASSAY | Oct 31, 1980 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.