Cleared Traditional

ECLIPSE ICA DIGOXIN

K905719 · Biotope, Inc. · Toxicology

Jan 1991

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K905719 is an FDA 510(k) clearance for the ECLIPSE ICA DIGOXIN, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on January 17, 1991, 27 days after receiving the submission on December 21, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K905719 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 1990
Decision Date	January 17, 1991
Days to Decision	27 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