Cleared Traditional

MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE

K903647 · Millipore Corp. · Chemistry
Sep 1990
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K903647 is an FDA 510(k) clearance for the MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE, 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, 1990, 33 days after receiving the submission on August 9, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K903647 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1990
Decision Date September 11, 1990
Days to Decision 33 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