DML — Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Class II
FDA product code DML covers "Nad-Nadh, Specific Reagent For Alcohol Enzyme Method", a Class II medical device regulated under 21 CFR 862.3040. Submissions are reviewed by the Clinical Toxicology panel. At least 13 recent 510(k) clearances have been granted under this product code.
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 |