Cleared Traditional

DIGOXIN COATED TUBE RIA

K922353 · Monobind · Toxicology
Aug 1992
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K922353 is an FDA 510(k) clearance for the DIGOXIN COATED TUBE RIA, a Radioimmunoassay, Digoxin (125-i) (Class II — Special Controls, product code LCS), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on August 24, 1992, 97 days after receiving the submission on May 19, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K922353 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1992
Decision Date August 24, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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