Cleared Traditional

INNOFLUOR DIGOXIN REAGENT SET

K895828 · Innotron of Oregon, Inc. · Toxicology
Oct 1989
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K895828 is an FDA 510(k) clearance for the INNOFLUOR DIGOXIN REAGENT SET, a Radioimmunoassay, Digoxin (125-i) (Class II — Special Controls, product code LCS), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on October 30, 1989, 28 days after receiving the submission on October 2, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K895828 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1989
Decision Date October 30, 1989
Days to Decision 28 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