Cleared Traditional

EXTRELUT QE EXTRACTION COLUMNS

K831027 · Emd Chemicals, Inc. · Toxicology
May 1983
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K831027 is an FDA 510(k) clearance for the EXTRELUT QE EXTRACTION COLUMNS, a Resins, Ion-exchange (Class I — General Controls, product code KEA), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983, 47 days after receiving the submission on March 30, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2230.

Submission Details

510(k) Number K831027 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1983
Decision Date May 16, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KEA — Resins, Ion-exchange
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2230

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