Cleared Traditional

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

K062372 · The Binding Site, Ltd. · Immunology
Jun 2007
Decision
311d
Days
Class 2
Risk

About This 510(k) Submission

K062372 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS 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 June 21, 2007, 311 days after receiving the submission on August 14, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K062372 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2006
Decision Date June 21, 2007
Days to Decision 311 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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