Cleared Traditional

K853021 - OPTIMATE DIGOXIN TEST
(FDA 510(k) Clearance)

K853021 · Miles Laboratories, Inc. · Toxicology

Aug 1985

Decision

20d

Days

Class 2

Risk

K853021 is an FDA 510(k) clearance for the OPTIMATE DIGOXIN TEST. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (Class II — Special Controls, product code DPB).

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 7, 1985, 20 days after receiving the submission on July 18, 1985.

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

Submission Details

510(k) Number	K853021 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 1985
Decision Date	August 07, 1985
Days to Decision	20 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