Cleared Traditional

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II

K031016 · The Binding Site, Ltd. · Immunology
Jul 2003
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K031016 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II, 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 July 15, 2003, 106 days after receiving the submission on March 31, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K031016 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date July 15, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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