Cleared Traditional

FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

K070900 · The Binding Site, Ltd. · Immunology
Nov 2007
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K070900 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT, 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 November 30, 2007, 242 days after receiving the submission on April 2, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K070900 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2007
Decision Date November 30, 2007
Days to Decision 242 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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