Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array Analyzer
FDA 510(k) K940422 · The Binding Site, Ltd.
510(k) numberK940422
Submission
- Device name
- Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array Analyzer
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- January 19, 1994
- Decision date
- May 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DFZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092283 | Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista…DFZ · Traditional | Siemens Healthcare Diagnostics | 10/21/2009SE |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | The Binding Site, Ltd. | 06/17/2002SE |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage KitDFZ · Traditional | Sanquin Blood Supply Foundation | 05/14/2002SE |
| K955906 | Boehringer Mannheim Igg AssayDFZ · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K812821 | H-103 Igg, H-104 Iga, H-105 IgmDFZ · Traditional | Immulok, Inc. | 10/26/1981SE |
| K803272 | Automated Immunoprecipitin Method/IcgDFZ · Traditional | Icl Scientific | 01/26/1981SE |
| K790720 | Antisera to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K790709 | Antiserum to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
More from Kent Laboratories, Inc.
| 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 Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array Analyzer cleared by the FDA?
Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array Analyzer (K940422) received a 510(k) decision of Substantially Equivalent on May 27, 1994, 128 days after the submission was received.
What is the product code of K940422?
The FDA product code is DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.