Cleared Traditional

K891673 - ADVANCED PURIFICATION GLASS COLUMN
(FDA 510(k) Clearance)

Apr 1989
Decision
36d
Days
Class 1
Risk

K891673 is an FDA 510(k) clearance for the ADVANCED PURIFICATION GLASS COLUMN. This device is classified as a Columns, Liquid Chromatography (Class I - General Controls, product code DPM).

Submitted by Waters Chemical Products (Milford, US). The FDA issued a Cleared decision on April 26, 1989, 36 days after receiving the submission on March 21, 1989.

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

Submission Details

510(k) Number K891673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1989
Decision Date April 26, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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