Atlas FDA

DFH

63 FDA 510(k) clearances · Product code

75 daysmedian time to decision
311 days90th percentile
63clearances measured

FDA profile

Official device name
Kappa, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358)Diazyme Laboratories, Inc.2025-12-19
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549)The Binding Site Group , Ltd.2025-05-23
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (K231601)Sebia2024-02-23
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (K231290)The Binding Site, Ltd.2024-01-24
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (K210623)Sebia2022-11-18
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K211648)Diazyme Laboratories, Inc.2022-09-08
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K220001)Diazyme Laboratories, Inc.2022-08-04
N Latex FLC kappa, N Latex FLC lambda (K212379)Siemens Healthcare Diagnostics Products GmbH2022-03-02
N Latex FLC kappa, N Latex FLC lambda (K201496)Siemens Healthcare Diagnostics Products GmbH2021-10-29
N Latex FLC kappa, N Latex FLC lambda (K193047)Siemens Healthcare Diagnostics Products GmbH2021-07-14
N Latex FLC kappa, N Latex FLC lambda (K190879)Siemens Healthcare Diagnostics Products GmbH2019-05-03
N Latex FLC kappa assay, N Latex FLC lambda assay (K182098)Siemens Healthcare Diagnostics Products GmbH2018-11-01
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (K173732)The Binding Site Group , Ltd.2018-08-23
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438)Diazyme Laboratories, Inc.2018-06-26
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (K171742)Siemens Healthcare Diagnostics Products GmbH2017-11-17
Diazyme 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 Calibrator (K153394)Diazyme Laboratories2016-11-18
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit (K150658)The Binding Site Group , Ltd.2015-08-26
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER (K120056)The Binding Site Group , Ltd.2013-04-01
KAPPA LIGHT CHAINS (K083602)SENTINEL CH. SpA2009-09-03
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL (K082503)Siemens Healthcare Diagnostics2008-12-19
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT (K070900)The Binding Site, Ltd.2007-11-30
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER (K062372)The Binding Site, Ltd.2007-06-21
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER (K051915)The Binding Site, Ltd.2005-09-06
CAPILLARY'S IMMUNOTYPING (PN 2100) (K042939)Sebia, Inc.2005-06-27
FREELITE HUMAN KAPPA AND LAMBDA KITS (K040009)The Binding Site, Ltd.2004-03-11
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER (K023009)The Binding Site, Ltd.2003-01-21
KAPPA IMMAGE FREELITE KIT (K003669)The Binding Site, Ltd.2001-02-01
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002564)The Binding Site, Ltd.2000-10-26
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG (K964260)Beckman Instruments, Inc.1997-02-10
CHEMMATE(TM) UCHL1 (CD45-RO) (K950152)Biotek Solutions, Inc.1995-10-27
CHEMMATE(TM) KAPPA (K950150)Biotek Solutions, Inc.1995-10-27
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) (K902484)Beckman Instruments, Inc.1990-06-21
BECKMAN LAMBDA LIGHT CHAIN REAGENT (K884597)Beckman Instruments, Inc.1988-12-06
BECKMAN KAPPA LIGHT CHAIN REAGENT (K884276)Beckman Instruments, Inc.1988-11-16
N-IMMUNOGLOBULIN LIGHT CHAIN KIT (K880341)Behring Diagnostics, Inc.1988-02-17
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK (K875164)Kallestad Diag, A Div. of Erbamont, Inc.1988-01-22
QUANTIMETRIC PLUS KAPPA REAGENT KIT (K855008)Kallestad Laboratories, Inc.1986-02-26
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM (K842470)Miles Laboratories, Inc.1984-08-28
AMER. HISTO-ID SYS PRIMARY KIT (K842326)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
FITC GOAT ANTI-HUMAN KAPPA AFFINITY (K832266)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN IMMUNOGLOBULINS- (K832256)Gelco Diagnostics, Inc.1983-10-31
ANTISERUM TO HUMAN IGA (K822668)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN IGG (K822676)Amico Lab, Inc.1982-11-17
ANTISERUM TO HUMAN KAPPA (K822666)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN IGM (K822677)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN KAPPA (K822673)Amico Lab, Inc.1982-11-17
ANTISERUM TO HUMAN IGM (K822670)Amico Lab, Inc.1982-11-17
ANTISERUM TO HUMAN LAMBDA (K822667)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN LAMBDA (K822674)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN C3 (K822679)Amico Lab, Inc.1982-11-17
ANTISERUM TO HUMAN IGG (K822669)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN GOBULIN (K822678)Amico Lab, Inc.1982-11-17
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA (K823121)Amico Lab, Inc.1982-11-17
ANTISERUM TO HUMAN GOBULIN (K822671)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN IGA (K822675)Amico Lab, Inc.1982-11-17
DAKO PAP KIT K504 (K812485)Dako Corp.1982-02-10
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA (K812661)Dako Corp.1981-09-29
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME (K811721)Immulok, Inc.1981-07-16
ANTISERA TO HUMAN FREE KAPPA CHAINS (K802283)Kallestad Laboratories, Inc.1980-10-23
ANTI-HUMAN KAPPA SERUM (K791284)Diagnostica, Inc.1979-11-27
ANTISERUM TO RABBIT IGG H & L CHAIN (K790706)Kent Laboratories, Inc.1979-09-12
KAPPA SERUM (FREE) ANTI-HUMAN (K781027)Icl Scientific1978-07-27
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN (K781028)Icl Scientific1978-07-27

Track DFH automatically

Every clearance here is in the API, with alerts when new ones post.