Cleared Traditional

K083601 - LAMBDA LIGHT CHAINS (FDA 510(k) Clearance)

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

K083601 is an FDA 510(k) clearance for the LAMBDA LIGHT CHAINS. This device is classified as a Lambda, Antigen, Antiserum, Control (Class II - Special Controls, product code DEH).

Submitted by SENTINEL CH. SpA (Milan, 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 FDA review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K083601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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