Cleared Traditional

WATERS(TM) 996 PDA

K924347 · Millipore Corp. · Toxicology
Dec 1992
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K924347 is an FDA 510(k) clearance for the WATERS(TM) 996 PDA, a Apparatus, High Pressure Liquid Chromatography (Class I — General Controls, product code KIE), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on December 11, 1992, 106 days after receiving the submission on August 27, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K924347 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1992
Decision Date December 11, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KIE — Apparatus, High Pressure Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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