Cleared Traditional

K810296 - DIGOXIN RIA ASSAY
(FDA 510(k) Clearance)

K810296 · Ria Diagnostics · Toxicology

Feb 1981

Decision

15d

Days

Class 2

Risk

K810296 is an FDA 510(k) clearance for the DIGOXIN RIA ASSAY, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (Class II — Special Controls, product code DON), submitted by Ria Diagnostics (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981, 15 days after receiving the submission on February 4, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K810296 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1981
Decision Date	February 19, 1981
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

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