Cleared Traditional

Immunalysis Ethyl Alcohol Enzyme Assay

K181553 · Immunalysis Corporation · Toxicology

Oct 2018

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K181553 is an FDA 510(k) clearance for the Immunalysis Ethyl Alcohol Enzyme Assay, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 31, 2018, 140 days after receiving the submission on June 13, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K181553 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2018
Decision Date	October 31, 2018
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3040