Cleared Traditional

DELFIA DIGOXIN KIT

K924594 · Wallac OY · Toxicology
Dec 1992
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K924594 is an FDA 510(k) clearance for the DELFIA DIGOXIN KIT, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on December 17, 1992, 98 days after receiving the submission on September 10, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K924594 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1992
Decision Date December 17, 1992
Days to Decision 98 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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