Cleared Traditional

DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM

K933955 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Oct 1993
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K933955 is an FDA 510(k) clearance for the DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 13, 1993, 62 days after receiving the submission on August 12, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K933955 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1993
Decision Date October 13, 1993
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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