Cleared Traditional

K861633 - LIQUID CHROMATOGRAPHY COLUMNS
(FDA 510(k) Clearance)

May 1986
Decision
24d
Days
Class 1
Risk

K861633 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 May 23, 1986, 24 days after receiving the submission on April 29, 1986.

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

Submission Details

510(k) Number K861633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 23, 1986
Days to Decision 24 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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