DML — Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Class II
FDA Device Classification
Classification Details
- Product Code
- DML
- Device Class
- Class II
- Regulation Number
- 862.3040
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K013538 | abbott laboratories | ETHANOL | December 14, 2001 |
| K993980 | syva | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | February 1, 2000 |
| K963197 | ansys | ON.SITE ALCOHOL | September 19, 1996 |
| K953765 | abbott laboratories | AXSYM REA ETHANOL | September 27, 1995 |
| K952839 | boehringer mannheim | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY | August 24, 1995 |
| K923337 | toxi-lab | ON*SITE ALCOHOL | January 12, 1993 |
| K914777 | sigma diagnostics | SIGMA PROCEDURE NO. 333-UV | December 27, 1991 |
| K874382 | reagents applications | RAICHEM(TM) ALCOHOL REAGENT | January 11, 1988 |
| K872180 | american monitor | KINETIC 610 ETHANOL | July 7, 1987 |
| K863419 | em diagnostic systems | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 | September 29, 1986 |
| K840769 | american dade | PARAMAX ALCOHOL REAGENT | April 13, 1984 |
| K840400 | syva | EMIT ST SERUM ETHYL ALCOHOL ASSAY | March 23, 1984 |
| K840171 | syva | EMIT ST URINE ETHYL ALCOHOL ASSAY | March 19, 1984 |