Human Igg Subclass Kit Use with the Beckman Image Analyzer
FDA 510(k) K000701 · The Binding Site, Ltd.
510(k) numberK000701
Submission
- Device name
- Human Igg Subclass Kit Use with the Beckman Image Analyzer
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- March 1, 2000
- Decision date
- April 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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More from The Binding Site Group , Ltd.
| 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 Human Igg Subclass Kit Use with the Beckman Image Analyzer cleared by the FDA?
Human Igg Subclass Kit Use with the Beckman Image Analyzer (K000701) received a 510(k) decision of Substantially Equivalent on April 27, 2000, 57 days after the submission was received.
What is the product code of K000701?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.