Cleared Traditional

LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD

K881868 · Supelco, Inc. · Toxicology
Aug 1988
Decision
118d
Days
Class 1
Risk

About This 510(k) Submission

K881868 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD, a Columns, Liquid Chromatography (Class I — General Controls, product code DPM), submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on August 29, 1988, 118 days after receiving the submission on May 3, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K881868 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1988
Decision Date August 29, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code DPM — Columns, Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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