Cleared Traditional

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL

K111005 · Medica Corp. · Toxicology
Nov 2011
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K111005 is an FDA 510(k) clearance for the ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 15, 2011, 218 days after receiving the submission on April 11, 2011. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K111005 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2011
Decision Date November 15, 2011
Days to Decision 218 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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