Cleared Traditional

FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER

K023009 · The Binding Site, Ltd. · Immunology
Jan 2003
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K023009 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 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 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 K023009 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 DFH — Kappa, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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