Cleared Traditional

TDX DIGOXIN

K820154 · Abbott Laboratories · Toxicology
Feb 1982
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K820154 is an FDA 510(k) clearance for the TDX DIGOXIN, a Radioimmunoassay, Digoxin (125-i) (Class II — Special Controls, product code LCS), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 5, 1982, 17 days after receiving the submission on January 19, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K820154 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1982
Decision Date February 05, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCS — Radioimmunoassay, Digoxin (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320