Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS— 510(k) K151759

Name: FDA 510(k) clearance K151759
Creator: U.S. Food and Drug Administration
Published: 2015-11-06

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K151759 for Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS, Substantially Equivalent on 2015-11-06. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code OPX
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2015-06-29
Decision date: 2015-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgbaston, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code OPX

view all

More clearances from The Binding Site Group , Ltd.

view all

K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser2025-10-17
K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit2025-05-23
K192116 — Human IgA liquid reagent kit for Use on SPAPlus2019-09-04
K191985 — Optilite IgA Kit2019-08-19
K191635 — Optilite IgM Kit2019-07-15

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