Cleared Traditional

ALLIANCE 2690 SEPARATIONS MODULE

K961557 · Waters Corporation · Toxicology
Jul 1996
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K961557 is an FDA 510(k) clearance for the ALLIANCE 2690 SEPARATIONS MODULE, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on July 5, 1996, 74 days after receiving the submission on April 22, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K961557 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1996
Decision Date July 05, 1996
Days to Decision 74 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

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