Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
FDA 510(k) K231290 · The Binding Site, Ltd.
510(k) numberK231290
Submission
- Device name
- Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- Applicant
- The Binding Site, Ltd.
Birmingham, GB - Received
- May 4, 2023
- Decision date
- January 24, 2024
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K190879 | N Latex FLC kappa, N Latex FLC lambdaDFH · Special | Siemens Healthcare Diagnostics Products GmbH | 05/03/2019SE |
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| K081674 | Bindazyme Human Anti-Gliadin (MGP), Igg Eia Kit; Bindazyme Human Anti-Gliadin (MGP) Iga…MST · Traditional | 10/15/2008SE |
Questions and answers
When was Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit cleared by the FDA?
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (K231290) received a 510(k) decision of Substantially Equivalent on January 24, 2024, 265 days after the submission was received.
What is the product code of K231290?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.