Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit
FDA 510(k) K132555 · The Binding Site
510(k) numberK132555
Submission
- Device name
- Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit
- Applicant
- The Binding Site
Birmingham, GB - Received
- August 14, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PCN – Immunoglobulin G Kappa Heavy And Light Chain Combined
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Other 510(k)s with product code PCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitPCN · Traditional | The Binding Site Group , Ltd. | 02/15/2018SE |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for…PCN · Traditional | The Binding Site Group , Ltd. | 10/04/2016SE |
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| K103824 | Human Iga Liquid Reagent Kit for Use on SPA PlusCFN · Traditional | 02/27/2012SE |
| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | 12/30/2009SE |
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
| 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 Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit cleared by the FDA?
Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit (K132555) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 128 days after the submission was received.
What is the product code of K132555?
The FDA product code is PCN – Immunoglobulin G Kappa Heavy And Light Chain Combined, a Class II (moderate risk) device regulated under 21 CFR 866.5510.