Cleared Traditional

FREELITE HUMAN LAMBDA FREE KIT

K140396 · The Binding Site Group , Ltd. · Immunology
Apr 2014
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K140396 is an FDA 510(k) clearance for the FREELITE HUMAN LAMBDA FREE KIT, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by The Binding Site Group , Ltd. (San Diego, US). The FDA issued a Cleared decision on April 16, 2014, 57 days after receiving the submission on February 18, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K140396 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2014
Decision Date April 16, 2014
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEH — Lambda, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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