Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
FDA 510(k) K173732 · The Binding Site Group , Ltd.
510(k) numberK173732
Submission
- Device name
- Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- December 6, 2017
- Decision date
- August 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | Diazyme Laboratories, Inc. | 12/19/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | The Binding Site Group , Ltd. | 05/23/2025SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 02/23/2024SE |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | The Binding Site, Ltd. | 01/24/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 11/18/2022SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 08/04/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 07/14/2021SE |
More from Siemens Healthcare Diagnostics Products GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG · Traditional | 10/17/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | 05/23/2025SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | 01/23/2019SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | 10/12/2018SE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite…DCN · Traditional | 02/28/2018SE |
Questions and answers
When was Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit cleared by the FDA?
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (K173732) received a 510(k) decision of Substantially Equivalent on August 23, 2018, 260 days after the submission was received.
What is the product code of K173732?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.