Cleared Traditional

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

K173732 · The Binding Site Group , Ltd. · Immunology
Aug 2018
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K173732 is an FDA 510(k) clearance for the Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 23, 2018, 260 days after receiving the submission on December 6, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K173732 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2017
Decision Date August 23, 2018
Days to Decision 260 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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