FDA.reportPublic FDA data

510(k) K231290

Device
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Applicant
The Binding Site, Ltd.
510(k) number
K231290
Product code
DFH
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-24
Date received
2023-05-04
Regulation
866.5550
Classification name
Kappa, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jolanta Wolff
Address
8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DFH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.2025-12-19
K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.2025-05-23
K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia2024-02-23
K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia2022-11-18
K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.2022-09-08
K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.2022-08-04
K212379N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2022-03-02
K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2021-10-29
K193047N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2021-07-14
K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH2019-05-03
K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH2018-11-01
K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.2018-08-23
K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.2018-06-26
K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH2017-11-17
K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories2016-11-18