Cleared Traditional

WATERS 717 AUTOSAMPLER

K920136 · Millipore Corp. · Toxicology
Feb 1992
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K920136 is an FDA 510(k) clearance for the WATERS 717 AUTOSAMPLER, 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 February 19, 1992, 37 days after receiving the submission on January 13, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K920136 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1992
Decision Date February 19, 1992
Days to Decision 37 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

Similar Devices — LDM Instrumentation, High Pressure Liquid Chromatography

All 18
CDM
K960392 · Bio-Rad · Jul 1996
ALLIANCE 2690 SEPARATIONS MODULE
K961557 · Waters Corporation · Jul 1996
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · Bio-Rad · Nov 1994
WATERS(TM) LC MODULE I FOR CLINICAL USE
K922388 · Millipore Corp. · Sep 1992
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K903647 · Millipore Corp. · Sep 1990
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · The Perkin-Elmer Corp. · Feb 1989