Cleared Traditional

AXSYM REA ETHANOL

K953765 · Abbott Laboratories · Toxicology
Sep 1995
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K953765 is an FDA 510(k) clearance for the AXSYM REA ETHANOL, a Nad-nadh, Specific Reagent For Alcohol Enzyme Method (Class II — Special Controls, product code DML), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 27, 1995, 47 days after receiving the submission on August 11, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K953765 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1995
Decision Date September 27, 1995
Days to Decision 47 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