Cleared Traditional

WATERS(TM) LC MODULE I FOR CLINICAL USE

K922388 · Millipore Corp. · Toxicology
Sep 1992
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K922388 is an FDA 510(k) clearance for the WATERS(TM) LC MODULE I FOR CLINICAL USE, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on September 11, 1992, 114 days after receiving the submission on May 20, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K922388 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1992
Decision Date September 11, 1992
Days to Decision 114 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDM — Instrumentation, High Pressure Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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