FDA Product Code
FDA Product Code DFH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5550
510(k) Clearances — 63 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2025-05-23 | Traditional | PDF ↗ |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | 2024-02-23 | Traditional | PDF ↗ |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. | 2024-01-24 | Traditional | PDF ↗ |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Sebia | 2022-11-18 | Traditional | PDF ↗ |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-09-08 | Traditional | PDF ↗ |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-08-04 | Traditional | PDF ↗ |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2022-03-02 | Traditional | PDF ↗ |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 | Traditional | PDF ↗ |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-07-14 | Traditional | PDF ↗ |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 | Special | PDF ↗ |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 | Traditional | PDF ↗ |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2018-08-23 | Traditional | PDF ↗ |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2018-06-26 | Special | PDF ↗ |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 | Traditional | PDF ↗ |
| K153394 | 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 | Diazyme Laboratories | 2016-11-18 | Traditional | PDF ↗ |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | The Binding Site Group , Ltd. | 2015-08-26 | Traditional | PDF ↗ |
| K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER | The Binding Site Group , Ltd. | 2013-04-01 | Traditional | PDF ↗ |
| K083602 | KAPPA LIGHT CHAINS | SENTINEL CH. SpA | 2009-09-03 | Traditional | PDF ↗ |
| K082503 | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL | Siemens Healthcare Diagnostics | 2008-12-19 | Traditional | PDF ↗ |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | The Binding Site, Ltd. | 2007-11-30 | Traditional | PDF ↗ |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | 2007-06-21 | Traditional | PDF ↗ |
| K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER | The Binding Site, Ltd. | 2005-09-06 | Traditional | PDF ↗ |
| K042939 | CAPILLARY'S IMMUNOTYPING (PN 2100) | Sebia, Inc. | 2005-06-27 | Traditional | PDF ↗ |
| K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | The Binding Site, Ltd. | 2004-03-11 | Traditional | PDF ↗ |
| K023009 | FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER | The Binding Site, Ltd. | 2003-01-21 | Traditional | PDF ↗ |
| K003669 | KAPPA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 | Traditional | PDF ↗ |
| K002564 | SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 | Traditional | PDF ↗ |
| K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG | Beckman Instruments, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K950152 | CHEMMATE(TM) UCHL1 (CD45-RO) | Biotek Solutions, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K950150 | CHEMMATE(TM) KAPPA | Biotek Solutions, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K902484 | BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) | Beckman Instruments, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K884597 | BECKMAN LAMBDA LIGHT CHAIN REAGENT | Beckman Instruments, Inc. | 1988-12-06 | Traditional | PDF ↗ |
| K884276 | BECKMAN KAPPA LIGHT CHAIN REAGENT | Beckman Instruments, Inc. | 1988-11-16 | Traditional | PDF ↗ |
| K880341 | N-IMMUNOGLOBULIN LIGHT CHAIN KIT | Behring Diagnostics, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K875164 | QM300 KAPPA LIGHT CHAINS ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K842470 | TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM | Miles Laboratories, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K842326 | AMER. HISTO-ID SYS PRIMARY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K822677 | FITC ANTISERA TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822666 | ANTISERUM TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822678 | FITC ANTISERA TO HUMAN GOBULIN | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822669 | ANTISERUM TO HUMAN IGG | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822675 | FITC ANTISERA TO HUMAN IGA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822668 | ANTISERUM TO HUMAN IGA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822670 | ANTISERUM TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822671 | ANTISERUM TO HUMAN GOBULIN | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822674 | FITC ANTISERA TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822679 | FITC ANTISERA TO HUMAN C3 | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822676 | FITC ANTISERA TO HUMAN IGG | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K823121 | RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822673 | FITC ANTISERA TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K822667 | ANTISERUM TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K812485 | DAKO PAP KIT K504 | Dako Corp. | 1982-02-10 | Traditional | PDF ↗ |
| K812661 | IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA | Dako Corp. | 1981-09-29 | Traditional | PDF ↗ |
| K811721 | H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME | Immulok, Inc. | 1981-07-16 | Traditional | PDF ↗ |
| K802283 | ANTISERA TO HUMAN FREE KAPPA CHAINS | Kallestad Laboratories, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K791284 | ANTI-HUMAN KAPPA SERUM | Diagnostica, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K790706 | ANTISERUM TO RABBIT IGG H & L CHAIN | Kent Laboratories, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K781028 | KAPPA SERUM (FREE & BOUND) ANTI-HUMAN | Icl Scientific | 1978-07-27 | Traditional | PDF ↗ |
| K781027 | KAPPA SERUM (FREE) ANTI-HUMAN | Icl Scientific | 1978-07-27 | Traditional | PDF ↗ |
Product code DFH · Class II · Immunology. Data: openFDA.