Cleared Traditional

DIGOXIN IMMUNOASSAY

K983323 · Diagnostic Reagents, Inc. · Toxicology
Nov 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K983323 is an FDA 510(k) clearance for the DIGOXIN 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 November 12, 1998, 51 days after receiving the submission on September 22, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K983323 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1998
Decision Date November 12, 1998
Days to Decision 51 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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