Optilite IgG4 Kit— 510(k) K150526

Name: FDA 510(k) clearance K150526
Creator: U.S. Food and Drug Administration
Published: 2015-05-30

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K150526 for Optilite IgG4 Kit, Substantially Equivalent on 2015-05-30. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2015-03-02
Decision date: 2015-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K150526

K-number listed on FDA's recall record

Z-1089-2017 — Optilite IgG4 Kit Product Code: LK009.OPT.AClass III·Terminated·The Binding Site Group, Ltd.·20161223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150526.

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