Cleared Traditional

LIQUID CHROMATOGRAPH 400

K843568 · The Perkin-Elmer Corp. · Toxicology
Nov 1984
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K843568 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPH 400, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on November 20, 1984, 71 days after receiving the submission on September 10, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K843568 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1984
Decision Date November 20, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KZR — Chromatography (liquid, Gel), Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260

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