Cleared Traditional

RIA COAT DIGOXIN

K833842 · Immuno Assay Corp. · Toxicology

Jan 1984

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K833842 is an FDA 510(k) clearance for the RIA COAT DIGOXIN, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984, 75 days after receiving the submission on November 3, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K833842 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1983
Decision Date	January 17, 1984
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

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