Freelite Human Lambda Free Kit
FDA 510(k) K140396 · The Binding Site Group , Ltd.
510(k) numberK140396
Submission
- Device name
- Freelite Human Lambda Free Kit
- Applicant
- The Binding Site Group , Ltd.
San Diego, CA, US - Received
- February 18, 2014
- Decision date
- April 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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| 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 |
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| 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 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH · Traditional | 08/23/2018SE |
Questions and answers
When was Freelite Human Lambda Free Kit cleared by the FDA?
Freelite Human Lambda Free Kit (K140396) received a 510(k) decision of Substantially Equivalent on April 16, 2014, 57 days after the submission was received.
What is the product code of K140396?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.