DFH — Kappa, Antigen, Antiserum, Control Class II
FDA product code DFH covers "Kappa, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5550. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DFH
- Device Class
- Class II
- Regulation Number
- 866.5550
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253358 | diazyme laboratories | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Li | December 19, 2025 |
| K250549 | binding site group | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | May 23, 2025 |
| K231601 | sebia | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | February 23, 2024 |
| K231290 | binding site | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | January 24, 2024 |
| K210623 | sebia | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | November 18, 2022 |
| K211648 | diazyme laboratories | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai | September 8, 2022 |
| K220001 | diazyme laboratories | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai | August 4, 2022 |
| K212379 | siemens healthcare diagnostics products | N Latex FLC kappa, N Latex FLC lambda | March 2, 2022 |
| K201496 | siemens healthcare diagnostics products | N Latex FLC kappa, N Latex FLC lambda | October 29, 2021 |
| K193047 | siemens healthcare diagnostics products | N Latex FLC kappa, N Latex FLC lambda | July 14, 2021 |
| K190879 | siemens healthcare diagnostics products | N Latex FLC kappa, N Latex FLC lambda | May 3, 2019 |
| K182098 | siemens healthcare diagnostics products | N Latex FLC kappa assay, N Latex FLC lambda assay | November 1, 2018 |
| K173732 | binding site group | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | August 23, 2018 |
| K181438 | diazyme laboratories | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chai | June 26, 2018 |
| K171742 | siemens healthcare diagnostics products | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Cont | November 17, 2017 |
| K153394 | diazyme laboratories | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai | November 18, 2016 |
| K150658 | binding site group | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | August 26, 2015 |
| K120056 | binding site group | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER | April 1, 2013 |
| K083602 | sentinel ch | KAPPA LIGHT CHAINS | September 3, 2009 |
| K082503 | siemens healthcare diagnostics | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TY | December 19, 2008 |