Cleared Traditional

K894141 - LIQUID CHROMATOGRAPHY COLUMNS
(FDA 510(k) Clearance)

Aug 1989
Decision
69d
Days
Class 1
Risk

K894141 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS. This device is classified as 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 21, 1989, 69 days after receiving the submission on June 13, 1989.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K894141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1989
Decision Date August 21, 1989
Days to Decision 69 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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