Cleared Traditional

DIGOXIN ENZYME IMMUNOASSAY

K963835 · Diagnostic Reagents, Inc. · Toxicology
Dec 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K963835 is an FDA 510(k) clearance for the DIGOXIN ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 10, 1996, 77 days after receiving the submission on September 24, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K963835 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1996
Decision Date December 10, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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