Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
The NAD-NADH Specific Reagent for the Alcohol Enzyme Method is a laboratory reagent used in enzymatic assays that measure alcohol concentrations based on the alcohol dehydrogenase reaction, with NAD/NADH serving as the coenzyme system. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DML, 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
- DML
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013538 | ETHANOL | Dec 14, 2001 | Substantially Equivalent | Abbott Laboratories |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Feb 01, 2000 | Substantially Equivalent | Syva Co. |
| K963197 | ON.SITE ALCOHOL | Sep 19, 1996 | Substantially Equivalent | Ansys, Inc. |
| K953765 | AXSYM REA ETHANOL | Sep 27, 1995 | Substantially Equivalent | Abbott Laboratories |
| K952839 | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY | Aug 24, 1995 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K923337 | ON*SITE ALCOHOL | Jan 12, 1993 | Substantially Equivalent | Toxi-Lab, Inc. |
| K914777 | SIGMA PROCEDURE NO. 333-UV | Dec 27, 1991 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K874382 | RAICHEM(TM) ALCOHOL REAGENT | Jan 11, 1988 | Substantially Equivalent | Reagents Applications, Inc. |
| K872180 | KINETIC 610 ETHANOL | Jul 07, 1987 | Substantially Equivalent | American Monitor Corp. |
| K863419 | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 | Sep 29, 1986 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K840769 | PARAMAX ALCOHOL REAGENT | Apr 13, 1984 | Substantially Equivalent | American Dade |
| K840400 | EMIT ST SERUM ETHYL ALCOHOL ASSAY | Mar 23, 1984 | Substantially Equivalent | Syva Co. |
| K840171 | EMIT ST URINE ETHYL ALCOHOL ASSAY | Mar 19, 1984 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.