Cleared Traditional

ETHYL ALCOHOL STANDARD

K882117 · Verichem Laboratories, Inc. · Toxicology
Aug 1988
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K882117 is an FDA 510(k) clearance for the ETHYL ALCOHOL STANDARD, a Calibrators, Ethyl Alcohol (Class II — Special Controls, product code DNN), submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on August 4, 1988, 77 days after receiving the submission on May 19, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K882117 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1988
Decision Date August 04, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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