Cleared Traditional

ISOPURE LC SYSTEM

K862178 · The Perkin-Elmer Corp. · Chemistry
Jul 1986
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K862178 is an FDA 510(k) clearance for the ISOPURE LC SYSTEM, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on July 14, 1986, 35 days after receiving the submission on June 9, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K862178 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1986
Decision Date July 14, 1986
Days to Decision 35 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