Cleared Traditional

FREELITE HUMAN LAMBDA FREE KIT

K023131 · The Binding Site, Ltd. · Immunology
Jan 2003
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K023131 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, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on January 21, 2003, 134 days after receiving the submission on September 9, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K023131 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2002
Decision Date January 21, 2003
Days to Decision 134 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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