Cleared Traditional

ETHANOL

K013538 · Abbott Laboratories · Toxicology
Dec 2001
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K013538 is an FDA 510(k) clearance for the ETHANOL, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on December 14, 2001, 51 days after receiving the submission on October 24, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K013538 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2001
Decision Date December 14, 2001
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DML — Nad-nadh, Specific Reagent For Alcohol Enzyme Method
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3040

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