Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls
FDA 510(k) K011663 · The Binding Site, Ltd.
510(k) numberK011663
Submission
- Device name
- Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 29, 2001
- Decision date
- July 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Specialty
- Immunology
Other 510(k)s with product code DEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123256 | Human ALPHA-1 Antitrypsin Kit SpaplusDEM · Traditional | The Binding Site Group , Ltd. | 07/03/2013SE |
| K063610 | Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…DEM · Traditional | Dade Behring, Inc. | 01/11/2007SE |
| K053072 | N Antisera to Human ALPHA1-ANTITRYPSINDEM · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…DEM · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/23/2005SE |
| K050596 | Quantia A1-ATDEM · Traditional | Biokit, S.A. | 05/13/2005SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | Bayer Diagnostics Corp. | 09/04/2003SE |
| K010978 | Tina-Quant ALPHA-1 AntitrypsinDEM · Traditional | Rochdiag | 05/18/2001SE |
| K993444 | K-Assay ALPHA-1 atDEM · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972640 | Tina-Quant Alpha PARTICLE-1-ANTITRYPSIN AssayDEM · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K973392 | Chemmate LambdaDEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
More from Ventana Medical Systems, 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 Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls cleared by the FDA?
Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls (K011663) received a 510(k) decision of Substantially Equivalent on July 30, 2001, 62 days after the submission was received.
What is the product code of K011663?
The FDA product code is DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.