Cleared Traditional

LEUKO EZ VUE

K071712 · Techlab Inc., Corporate Research Center · Immunology

Dec 2007

Decision

165d

Days

Class 1

Risk

About This 510(k) Submission

K071712 is an FDA 510(k) clearance for the LEUKO EZ VUE, a Lactoferrin, Antigen, Antiserum, Control (Class I — General Controls, product code DEG), submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on December 4, 2007, 165 days after receiving the submission on June 22, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5570.

Submission Details

510(k) Number	K071712 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2007
Decision Date	December 04, 2007
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF