Immunoglobulins G, a & M Light Chain Specific
FDA 510(k) K924767 · The Binding Site, Ltd.
510(k) numberK924767
Submission
- Device name
- Immunoglobulins G, a & M Light Chain Specific
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- September 23, 1992
- Decision date
- February 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | Sebia | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | Sebia | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | Sebia | 05/02/2019SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | Sebia | 01/11/2018SE |
| K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, It/If ControlCFF · Traditional | Sebia | 12/21/2016SE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | Sebia | 01/08/2015SE |
| K120169 | Interlab Ife Test Using G 26 Ver. 2.0 InstrumentCFF · Traditional | Grifols USA, LLC | 08/24/2012SE |
| K111369 | The Helena V8 Immunodisplacement KitCFF · Traditional | Helena Laboratories Uk, Ltd. | 06/26/2012SE |
| K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentCFF · Traditional | Grifols | 10/13/2011SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | Sebia | 04/17/2009SE |
More from Sebia
| 510(k) | Device | Decision |
|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | 01/24/2024SE |
| K140105 | Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for…OPX · Traditional | 03/18/2014SE |
| K132555 | Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional | 12/20/2013SE |
| 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 |
Questions and answers
When was Immunoglobulins G, a & M Light Chain Specific cleared by the FDA?
Immunoglobulins G, a & M Light Chain Specific (K924767) received a 510(k) decision of Substantially Equivalent on February 23, 1993, 153 days after the submission was received.
What is the product code of K924767?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.