Cleared Traditional

KAPPA LIGHT CHAINS

K083602 · SENTINEL CH. SpA · Immunology
Sep 2009
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K083602 is an FDA 510(k) clearance for the KAPPA LIGHT CHAINS, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on September 3, 2009, 272 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 K083602 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2008
Decision Date September 03, 2009
Days to Decision 272 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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