FDA.reportPublic FDA data

510(k) K231601

Device
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
Applicant
Sebia
510(k) number
K231601
Product code
DFH
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-23
Date received
2023-06-01
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
No

Applicant Contact#

Contact
Karen Anderson
Address
1705 Corporate Dr., Suite 400 Norcross GA US 30093 30093

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
K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.2024-01-24
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