Cleared Traditional

DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM

K944093 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Nov 1994
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K944093 is an FDA 510(k) clearance for the DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 10, 1994, 80 days after receiving the submission on August 22, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K944093 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1994
Decision Date November 10, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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