Cleared Traditional

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

K973054 · Emd Chemicals, Inc. · Toxicology
Oct 1997
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K973054 is an FDA 510(k) clearance for the ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS, a Calibrators, Ethyl Alcohol (Class II — Special Controls, product code DNN), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on October 1, 1997, 47 days after receiving the submission on August 15, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K973054 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1997
Decision Date October 01, 1997
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DNN — Calibrators, Ethyl Alcohol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200