Cleared Traditional

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

K023058 · Seradyn · Toxicology

Oct 2002

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K023058 is an FDA 510(k) clearance for the QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Seradyn (Indianapolis, US). The FDA issued a Cleared decision on October 24, 2002, 41 days after receiving the submission on September 13, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K023058 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2002
Decision Date	October 24, 2002
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF