Cleared Traditional

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER

K033811 · The Binding Site, Ltd. · Immunology
Jan 2004
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K033811 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER, 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 30, 2004, 52 days after receiving the submission on December 9, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K033811 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2003
Decision Date January 30, 2004
Days to Decision 52 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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