Cleared Traditional

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

K051915 · The Binding Site, Ltd. · Immunology
Sep 2005
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K051915 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER, 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 September 6, 2005, 53 days after receiving the submission on July 15, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K051915 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2005
Decision Date September 06, 2005
Days to Decision 53 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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