Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit
FDA 510(k) K062183 · The Binding Site, Ltd.
510(k) numberK062183
Submission
- Device name
- Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- July 31, 2006
- Decision date
- November 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LRM
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|---|---|---|---|
| K101319 | Immulisa Dsdna Antibody ElisaLRM · Traditional | Immco Diagnostics, Inc. | 12/09/2010SE |
| K083381 | Euroimmun Anti-Dsdna-Ncx Elisa (Igg)LRM · Traditional | Euroimmun Us, Inc. | 04/15/2009SE |
| K040811 | Varelisa Ssdna Antibodies, Model 14896LRM · Traditional | Pharmacia Deutschland GmbH | 05/13/2004SE |
| K001900 | Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional | Helix Diagnostics, Inc. | 09/11/2000SE |
| K000477 | Mdi Ds-Dna TestLRM · Traditional | Micro Detect, Inc. | 03/01/2000SE |
| K994424 | Diamedix Is-Anti-Dsdna Test SystemLRM · Traditional | Diamedix Corp. | 02/18/2000SE |
| K993727 | Bindazyme Anti-Dsdna Eia KitLRM · Traditional | The Binding Site, Ltd. | 12/21/1999SE |
| K984396 | Liquichek Anti-Dsdna Control, Model 213LRM · Traditional | Bio-Rad | 12/18/1998SE |
| K983422 | The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent…LRM · Traditional | Zeus Scientific, Inc. | 11/18/1998SE |
| K980391 | Seraquest Anti-DsdnaLRM · Traditional | Quest Intl., Inc. | 04/24/1998SE |
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Questions and answers
When was Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit cleared by the FDA?
Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit (K062183) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 113 days after the submission was received.
What is the product code of K062183?
The FDA product code is LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.