FDA 510(k) Applications for Medical Device Product Code "DFH"
(Kappa, Antigen, Antiserum, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964260 | BECKMAN INSTRUMENTS, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG | 02/10/1997 |
| 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 |
| K211648 | Diazyme Laboratories Inc. | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | 09/08/2022 |
| K220001 | Diazyme Laboratories Inc. | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | 08/04/2022 |
| K181438 | Diazyme Laboratories Inc. | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | 06/26/2018 |
| K210623 | Sebia | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | 11/18/2022 |
| K231601 | Sebia | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | 02/23/2024 |
| 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 |
| K182098 | Siemens Healthcare Diagnostics Products GmbH | N Latex FLC kappa assay, N Latex FLC lambda assay | 11/01/2018 |
| 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 |
| K190879 | Siemens Healthcare Diagnostics Products GmbH | N Latex FLC kappa, N Latex FLC lambda | 05/03/2019 |
| K212379 | Siemens Healthcare Diagnostics Products GmbH | N Latex FLC kappa, N Latex FLC lambda | 03/02/2022 |
| K193047 | Siemens Healthcare Diagnostics Products GmbH | N Latex FLC kappa, N Latex FLC lambda | 07/14/2021 |
| K201496 | Siemens Healthcare Diagnostics Products GmbH | N Latex FLC kappa, N Latex FLC lambda | 10/29/2021 |
| 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 |
| K250549 | The Binding Site Group Ltd | Optilite« Freelite Mx Kappa Free Kit; Optilite« Freelite Mx Lambda Free Kit | 05/23/2025 |
| K231290 | The Binding Site Ltd. | Optilite« Freelite« Kappa Free Kit, Optilite« Freelite« Lambda Free Kit | 01/24/2024 |
| 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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