Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit— 510(k) K173732

Name: FDA 510(k) clearance K173732
Creator: U.S. Food and Drug Administration
Published: 2018-08-23

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K173732 for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit, Substantially Equivalent on 2018-08-23. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DFH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 2017-12-06
Decision date: 2018-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFH

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Recalls naming K173732

K-number listed on FDA's recall record

Z-0943-2021 — Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.AClass II·Terminated·The Binding Site Group, Ltd.·20201118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173732.

Data sourced from openFDA. This site is unofficial and independent of the FDA.