Cleared Traditional

IBD-QUIK CHEK

K030704 · Techlab, Inc. · Immunology

Apr 2003

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K030704 is an FDA 510(k) clearance for the IBD-QUIK CHEK, a Lactoferrin, Antigen, Antiserum, Control (Class I — General Controls, product code DEG), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 21, 2003, 46 days after receiving the submission on March 6, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5570.

Submission Details

510(k) Number	K030704 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2003
Decision Date	April 21, 2003
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF