Cleared Traditional

FREELITE HUMAN KAPPA AND LAMBDA KITS

K040009 · The Binding Site, Ltd. · Immunology
Mar 2004
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K040009 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA KITS, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on March 11, 2004, 69 days after receiving the submission on January 2, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K040009 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2004
Decision Date March 11, 2004
Days to Decision 69 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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