Cleared Traditional

IBD-CHEK

K011396 · Techlab, Inc. · Immunology
Jun 2001
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K011396 is an FDA 510(k) clearance for the IBD-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 June 18, 2001, 42 days after receiving the submission on May 7, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5570.

Submission Details

510(k) Number K011396 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2001
Decision Date June 18, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEG — Lactoferrin, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5570