Cleared Traditional

Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit

K150658 · The Binding Site Group , Ltd. · Immunology
Aug 2015
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K150658 is an FDA 510(k) clearance for the Optilite FreeLite Kappa Free Kit, Optilite Freelite 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 26, 2015, 166 days after receiving the submission on March 13, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K150658 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2015
Decision Date August 26, 2015
Days to Decision 166 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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