Cleared Traditional

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

K231601 · Sebia · Immunology
Feb 2024
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K231601 is an FDA 510(k) clearance for the FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on February 23, 2024, 267 days after receiving the submission on June 1, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K231601 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2023
Decision Date February 23, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFH — Kappa, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

Similar Devices — DFH Kappa, Antigen, Antiserum, Control

All 62
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (?) Free Light Chain Assay
K253358 · Diazyme Laboratories, Inc. · Dec 2025
Optilite? Freelite Mx Kappa Free Kit; Optilite? Freelite Mx Lambda Free Kit
K250549 · The Binding Site Group , Ltd. · May 2025
Optilite? Freelite? Kappa Free Kit, Optilite? Freelite? Lambda Free Kit
K231290 · The Binding Site, Ltd. · Jan 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K211648 · Diazyme Laboratories, Inc. · Sep 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K220001 · Diazyme Laboratories, Inc. · Aug 2022