DMT — Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Class II
FDA Device Classification
Classification Details
- Product Code
- DMT
- 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 |
|---|
| K000410 | beckman coulter | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | April 10, 2000 |
| K971506 | beckman instruments | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | June 3, 1997 |
| K934273 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | March 21, 1994 |
| K923783 | diagnostic reagents | ETHYL ALCOHOL ASSAY | January 21, 1993 |
| K864894 | em diagnostic systems | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | January 9, 1987 |
| K843378 | diagnostic chemicals, ltd. (usa) | ETHYL ALCOHOL ASSAY KIT | September 14, 1984 |
| K810467 | syva | EMIT-ST SERUM ETHYL ALCOHOL ASSAY | March 6, 1981 |
| K802621 | syva | EMIT-STM ETHYL ALCOHOL ASSAY | October 31, 1980 |