Cleared Traditional

DIGOXIN FLEX(TM) REAGENT CARTRIDGE

K946153 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Feb 1995
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K946153 is an FDA 510(k) clearance for the DIGOXIN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 22, 1995, 68 days after receiving the submission on December 16, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K946153 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1994
Decision Date February 22, 1995
Days to Decision 68 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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