Cleared Traditional

LAMBDA LIGHT CHAINS

K083601 · SENTINEL CH. SpA · Immunology
Jun 2009
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K083601 is an FDA 510(k) clearance for the LAMBDA LIGHT CHAINS, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on June 22, 2009, 199 days after receiving the submission on December 5, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K083601 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2008
Decision Date June 22, 2009
Days to Decision 199 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

Similar Devices — DEH Lambda, Antigen, Antiserum, Control

All 52
VENTANA CD30 (Ber-H2) RxDx Assay
K172471 · Ventana Medical Systems, Inc. · May 2018
FREELITE HUMAN LAMBDA FREE KIT
K140396 · The Binding Site Group , Ltd. · Apr 2014
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · The Binding Site, Ltd. · Jan 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
K031016 · The Binding Site, Ltd. · Jul 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · The Binding Site, Ltd. · Jan 2003
FREELITE LAMBDA FREE KIT
K010440 · The Binding Site, Ltd. · Apr 2001