Cleared Traditional

IMMULITE DIGOXIN

K914833 · Cirrus Diagnostics, Inc. · Toxicology

Nov 1991

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K914833 is an FDA 510(k) clearance for the IMMULITE DIGOXIN, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on November 22, 1991, 28 days after receiving the submission on October 25, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K914833 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 1991
Decision Date	November 22, 1991
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

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