ClearanceBrief
Panels › Immunology › Product code DFH · Class 2

Kappa, Antigen, Antiserum, Control

Regulation 866.5550

1510(k)s in 12 months (63 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in DFH

Company510(k)sRecalls
Amico Lab, Inc.140
The Binding Site, Ltd.80
The Binding Site Group , Ltd.42
Siemens Healthcare Diagnostics Products GmbH60
Diazyme Laboratories50
Beckman Instruments, Inc.40
Sebia30
Biotek Solutions, Inc.20
Dako Corp.20
Gelco Diagnostics, Inc.20
Decided510(k)Device and applicantCode
Dec 19, 2025K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
Diazyme Laboratories, Inc.
DFH
May 23, 2025K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
The Binding Site Group , Ltd., GB
DFH
Feb 23, 2024K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
Sebia
DFH
Jan 24, 2024K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
The Binding Site, Ltd., GB
DFH
Nov 18, 2022K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Sebia
DFH
Sep 8, 2022K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
DFH
Aug 4, 2022K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
DFH
Mar 2, 2022K212379N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Oct 29, 2021K201496N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Jul 14, 2021K193047N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
May 3, 2019K190879N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Nov 1, 2018K182098N Latex FLC kappa assay, N Latex FLC lambda assay
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Aug 23, 2018K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
The Binding Site Group , Ltd., GB
DFH
Jun 26, 2018K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
DFH
Nov 17, 2017K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
Siemens Healthcare Diagnostics Products GmbH, DE
DFH
Nov 18, 2016K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free
Diazyme Laboratories
DFH
Aug 26, 2015K150658Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
The Binding Site Group , Ltd., GB
DFH
Apr 1, 2013K120056HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
The Binding Site Group , Ltd., GB
DFH
Sep 3, 2009K083602KAPPA LIGHT CHAINS
SENTINEL CH. SpA, IT
DFH
Dec 19, 2008K082503DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
Siemens Healthcare Diagnostics
DFH
Nov 30, 2007K070900FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
The Binding Site, Ltd.
DFH
Jun 21, 2007K062372FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
The Binding Site, Ltd.
DFH
Sep 6, 2005K051915FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
The Binding Site, Ltd.
DFH
Jun 27, 2005K042939CAPILLARY'S IMMUNOTYPING (PN 2100)
Sebia, Inc.
DFH
Mar 11, 2004K040009FREELITE HUMAN KAPPA AND LAMBDA KITS
The Binding Site, Ltd.
DFH
Jan 21, 2003K023009FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
The Binding Site, Ltd.
DFH
Feb 1, 2001K003669KAPPA IMMAGE FREELITE KIT
The Binding Site, Ltd.
DFH
Oct 26, 2000K002564SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
The Binding Site, Ltd.
DFH
Feb 10, 1997K964260IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
Beckman Instruments, Inc.
DFH
Oct 27, 1995K950152CHEMMATE(TM) UCHL1 (CD45-RO)
Biotek Solutions, Inc.
DFH
Oct 27, 1995K950150CHEMMATE(TM) KAPPA
Biotek Solutions, Inc.
DFH
Jun 21, 1990K902484BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
Beckman Instruments, Inc.
DFH
Dec 6, 1988K884597BECKMAN LAMBDA LIGHT CHAIN REAGENT
Beckman Instruments, Inc.
DFH
Nov 16, 1988K884276BECKMAN KAPPA LIGHT CHAIN REAGENT
Beckman Instruments, Inc.
DFH
Feb 17, 1988K880341N-IMMUNOGLOBULIN LIGHT CHAIN KIT
Behring Diagnostics, Inc.
DFH
Jan 22, 1988K875164QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DFH
Feb 26, 1986K855008QUANTIMETRIC PLUS KAPPA REAGENT KIT
Kallestad Laboratories, Inc.
DFH
Aug 28, 1984K842470TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
Miles Laboratories, Inc.
DFH
Aug 2, 1984K842326AMER. HISTO-ID SYS PRIMARY KIT
Bartels Immunodiagnostic Supplies, Inc.
DFH
Oct 31, 1983K832266FITC GOAT ANTI-HUMAN KAPPA AFFINITY
Gelco Diagnostics, Inc.
DFH
Oct 31, 1983K832256GOAT ANTI-HUMAN IMMUNOGLOBULINS-
Gelco Diagnostics, Inc.
DFH
Nov 17, 1982K823121RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
Amico Lab, Inc.
DFH
Nov 17, 1982K822679FITC ANTISERA TO HUMAN C3
Amico Lab, Inc.
DFH
Nov 17, 1982K822678FITC ANTISERA TO HUMAN GOBULIN
Amico Lab, Inc.
DFH
Nov 17, 1982K822677FITC ANTISERA TO HUMAN IGM
Amico Lab, Inc.
DFH
Nov 17, 1982K822676FITC ANTISERA TO HUMAN IGG
Amico Lab, Inc.
DFH
Nov 17, 1982K822675FITC ANTISERA TO HUMAN IGA
Amico Lab, Inc.
DFH
Nov 17, 1982K822674FITC ANTISERA TO HUMAN LAMBDA
Amico Lab, Inc.
DFH
Nov 17, 1982K822673FITC ANTISERA TO HUMAN KAPPA
Amico Lab, Inc.
DFH
Nov 17, 1982K822671ANTISERUM TO HUMAN GOBULIN
Amico Lab, Inc.
DFH

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