Cleared Traditional

FREELITE LAMBDA FREE KIT

K010440 · The Binding Site, Ltd. · Immunology
Apr 2001
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K010440 is an FDA 510(k) clearance for the FREELITE LAMBDA FREE KIT, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 26, 2001, 72 days after receiving the submission on February 13, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K010440 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2001
Decision Date April 26, 2001
Days to Decision 72 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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