Cleared Traditional

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

K990516 · Emd Chemicals, Inc. · Toxicology
Mar 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K990516 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 March 31, 1999, 41 days after receiving the submission on February 18, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K990516 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1999
Decision Date March 31, 1999
Days to Decision 41 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