FDA 510(k) Applications for Medical Device Product Code "DFH"
(Kappa, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K822671 AMICO LAB, INC. ANTISERUM TO HUMAN GOBULIN 11/17/1982
K822668 AMICO LAB, INC. ANTISERUM TO HUMAN IGA 11/17/1982
K822669 AMICO LAB, INC. ANTISERUM TO HUMAN IGG 11/17/1982
K822670 AMICO LAB, INC. ANTISERUM TO HUMAN IGM 11/17/1982
K822666 AMICO LAB, INC. ANTISERUM TO HUMAN KAPPA 11/17/1982
K822667 AMICO LAB, INC. ANTISERUM TO HUMAN LAMBDA 11/17/1982
K822679 AMICO LAB, INC. FITC ANTISERA TO HUMAN C3 11/17/1982
K822678 AMICO LAB, INC. FITC ANTISERA TO HUMAN GOBULIN 11/17/1982
K822675 AMICO LAB, INC. FITC ANTISERA TO HUMAN IGA 11/17/1982
K822676 AMICO LAB, INC. FITC ANTISERA TO HUMAN IGG 11/17/1982
K822677 AMICO LAB, INC. FITC ANTISERA TO HUMAN IGM 11/17/1982
K822673 AMICO LAB, INC. FITC ANTISERA TO HUMAN KAPPA 11/17/1982
K822674 AMICO LAB, INC. FITC ANTISERA TO HUMAN LAMBDA 11/17/1982
K823121 AMICO LAB, INC. RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA 11/17/1982
K842326 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. AMER. HISTO-ID SYS PRIMARY KIT 08/02/1984
K884276 BECKMAN INSTRUMENTS, INC. BECKMAN KAPPA LIGHT CHAIN REAGENT 11/16/1988
K902484 BECKMAN INSTRUMENTS, INC. BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) 06/21/1990
K884597 BECKMAN INSTRUMENTS, INC. BECKMAN LAMBDA LIGHT CHAIN REAGENT 12/06/1988
K964260 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG 02/10/1997
K880341 BEHRING DIAGNOSTICS, INC. N-IMMUNOGLOBULIN LIGHT CHAIN KIT 02/17/1988
K950150 BIOTEK SOLUTIONS, INC. CHEMMATE(TM) KAPPA 10/27/1995
K950152 BIOTEK SOLUTIONS, INC. CHEMMATE(TM) UCHL1 (CD45-RO) 10/27/1995
K812485 DAKO CORP. DAKO PAP KIT K504 02/10/1982
K812661 DAKO CORP. IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA 09/29/1981
K791284 DIAGNOSTICA, INC. ANTI-HUMAN KAPPA SERUM 11/27/1979
K153394 Diazyme Laboratories 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 11/18/2016
K181438 Diazyme Laboratories Inc. Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay 06/26/2018
K832266 GELCO DIAGNOSTICS, INC. FITC GOAT ANTI-HUMAN KAPPA AFFINITY 10/31/1983
K832256 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN IMMUNOGLOBULINS- 10/31/1983
K781028 ICL SCIENTIFIC KAPPA SERUM (FREE & BOUND) ANTI-HUMAN 07/27/1978
K781027 ICL SCIENTIFIC KAPPA SERUM (FREE) ANTI-HUMAN 07/27/1978
K811721 IMMULOK, INC. H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME 07/16/1981
K875164 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 KAPPA LIGHT CHAINS ANTIBODY PACK 01/22/1988
K802283 KALLESTAD LABORATORIES, INC. ANTISERA TO HUMAN FREE KAPPA CHAINS 10/23/1980
K855008 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS KAPPA REAGENT KIT 02/26/1986
K790706 KENT LABORATORIES, INC. ANTISERUM TO RABBIT IGG H & L CHAIN 09/12/1979
K842470 MILES LABORATORIES, INC. TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM 08/28/1984
K042939 Sebia, Inc. CAPILLARY'S IMMUNOTYPING (PN 2100) 06/27/2005
K083602 SENTINEL CH. SpA KAPPA LIGHT CHAINS 09/03/2009
K082503 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL 12/19/2008
K171742 Siemens Healthcare Diagnostics Products GmbH N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 11/17/2017
K120056 THE BINDING SITE GROUP LTD HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER 04/01/2013
K150658 THE BINDING SITE GROUP LTD Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit 08/26/2015
K173732 The Binding Site Group Ltd Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit 08/23/2018
K023009 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER 01/21/2003
K070900 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT 11/30/2007
K062372 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER 06/21/2007
K051915 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER 09/06/2005
K040009 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA KITS 03/11/2004
K003669 THE BINDING SITE, LTD. KAPPA IMMAGE FREELITE KIT 02/01/2001
K002564 THE BINDING SITE, LTD. SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT 10/26/2000


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