Cleared Traditional

K823014 - DIGOXIN KIT
(FDA 510(k) Clearance)

K823014 · Pcl-Ria, Inc. · Toxicology

Nov 1982

Decision

19d

Days

Class 2

Risk

K823014 is an FDA 510(k) clearance for the DIGOXIN KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (Class II — Special Controls, product code DPB).

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 19 days after receiving the submission on October 13, 1982.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K823014 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 1982
Decision Date	November 01, 1982
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

Product Code	DPB — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3320