DIC

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Product code: DIC
Device name: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device class: Class 2
21 CFR: 21 CFR 862.3040
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 33

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-09-15.

Number	Decision date	Applicant	Device name	Summary
K250609	2025-09-15	Sober Ip, LLC	Sober Self-Test	PDF

1 summaries are archived here for direct download.

Official FDA classification page: DIC

Classification and pathway per current FDA publications. Data from openFDA (CC0).