Cleared Traditional

DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM

K864230 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Nov 1986
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K864230 is an FDA 510(k) clearance for the DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM, a Acid Phosphatase, Thymolphthale Inmonophosphate (Class II — Special Controls, product code CKE), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 28, 1986, 31 days after receiving the submission on October 28, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K864230 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1986
Decision Date November 28, 1986
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKE — Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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