Cleared Traditional

WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM

K870949 · Millipore Corp. · Chemistry
Apr 1987
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K870949 is an FDA 510(k) clearance for the WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM, 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 April 22, 1987, 43 days after receiving the submission on March 10, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K870949 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1987
Decision Date April 22, 1987
Days to Decision 43 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