DeviceClearance

Product code DIC— Clinical Toxicology

ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS

Classification name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device class
Class 2
Regulation
21 CFR 862.3040
Advisory panel
Clinical Toxicology
Total cleared
33
First cleared
Most recent

Market context for product code DIC

FDA has cleared 33 devices under product code DIC between 1977 and 2025, filed by 23 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

last 15 years

Top applicants under product code DIC

Recent clearances under product code DIC

Data sourced from openFDA. This site is unofficial and independent of the FDA.