Product code DMT— Clinical Toxicology
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
- Classification name
- Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Device class
- Class 2
- Regulation
- 21 CFR 862.3040
- Advisory panel
- Clinical Toxicology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code DMT
FDA has cleared devices under product code DMT between 1980 and 2000, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1997
- 1994
- 1993
- 1987
- 1984
- 1981
- 1980
Top applicants under product code DMT
Recent clearances under product code DMT
- K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
- K971506 — SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
- K934273 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
- K923783 — ETHYL ALCOHOL ASSAY
- K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
- K843378 — ETHYL ALCOHOL ASSAY KIT
- K810467 — EMIT-ST SERUM ETHYL ALCOHOL ASSAY
- K802621 — EMIT-STM ETHYL ALCOHOL ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.