Cleared Traditional

DUPONT ACA DIGOXIN (DGN A) METHOD

K951441 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Jun 1995
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K951441 is an FDA 510(k) clearance for the DUPONT ACA DIGOXIN (DGN A) METHOD, 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 June 1, 1995, 64 days after receiving the submission on March 29, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K951441 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1995
Decision Date June 01, 1995
Days to Decision 64 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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