Cleared Traditional

PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP

K935666 · The Perkin-Elmer Corp. · Toxicology
Apr 1994
Decision
151d
Days
Class 1
Risk

About This 510(k) Submission

K935666 is an FDA 510(k) clearance for the PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP, a Apparatus, High Pressure Liquid Chromatography (Class I — General Controls, product code KIE), submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on April 26, 1994, 151 days after receiving the submission on November 26, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K935666 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1993
Decision Date April 26, 1994
Days to Decision 151 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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