Bindazyme CLQ Cic Eia Kit
FDA 510(k) K031563 · The Binding Site, Ltd.
510(k) numberK031563
Submission
- Device name
- Bindazyme CLQ Cic Eia Kit
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 19, 2003
- Decision date
- September 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAK – Complement C1q, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code DAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032254 | Ibl C1Q-CIC Cia TestDAK · Traditional | Ibl GmbH | 08/29/2003SE |
| K012576 | CIC-C1Q EiaDAK · Traditional | American Laboratory Products Co., Ltd. | 01/29/2002SE |
| K973203 | Thymostat Elisa for the Detection of Human Igg,M and a Anti-Rabbit Igg AntibodiesDAK · Traditional | Sangstat Medical Corp. | 09/30/1998SE |
| K972873 | Immustrip Hama IggDAK · Traditional | Immunomedics, Inc. | 03/17/1998SE |
| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | Kent Laboratories, Inc. | 05/30/1995SE |
| K914388 | C1 Rid KitDAK · Traditional | The Binding Site, Ltd. | 10/28/1991SE |
| K882829 | Circulating Immune Complexes ControlsDAK · Traditional | Cytotech, Inc. | 08/04/1988SE |
| K860996 | Sanassay Ic TestDAK · Traditional | Scientific Sales Intl., Inc. | 03/30/1987SE |
| K864312 | Ic MicroassayDAK · Traditional | Diamedix Corp. | 01/09/1987SE |
| K862649 | Cytotech Cic Enzyme ImmunoassayDAK · Traditional | Cytotech, Inc. | 09/04/1986SE |
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| K132555 | Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional | 12/20/2013SE |
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| 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 |
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Questions and answers
When was Bindazyme CLQ Cic Eia Kit cleared by the FDA?
Bindazyme CLQ Cic Eia Kit (K031563) received a 510(k) decision of Substantially Equivalent on September 10, 2003, 114 days after the submission was received.
What is the product code of K031563?
The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.