Cleared Traditional

WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D

K850359 · Millipore Corp. · Chemistry
Mar 1985
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K850359 is an FDA 510(k) clearance for the WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D, 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 March 5, 1985, 34 days after receiving the submission on January 30, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K850359 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1985
Decision Date March 05, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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