Cleared Traditional

K862067 - STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
(FDA 510(k) Clearance)

K862067 · American Dade · Toxicology

Jun 1986

Decision

17d

Days

Class 2

Risk

K862067 is an FDA 510(k) clearance for the STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY. This device is classified as a Enzyme Immunoassay, Digitoxin (Class II — Special Controls, product code LFM).

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on June 16, 1986, 17 days after receiving the submission on May 30, 1986.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3300.

Submission Details

510(k) Number	K862067 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1986
Decision Date	June 16, 1986
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—