Euroimmun Anti-Dsdna-Ncx Elisa (Igg)
FDA 510(k) K083381 · Euroimmun Us, Inc.
510(k) numberK083381
Submission
- Device name
- Euroimmun Anti-Dsdna-Ncx Elisa (Igg)
- Applicant
- Euroimmun Us, Inc.
Morristown, NJ, US - Received
- November 14, 2008
- Decision date
- April 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101319 | Immulisa Dsdna Antibody ElisaLRM · Traditional | Immco Diagnostics, Inc. | 12/09/2010SE |
| K062183 | Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay KitLRM · Traditional | The Binding Site, Ltd. | 11/21/2006SE |
| 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 Euroimmun Anti-Dsdna-Ncx Elisa (Igg) cleared by the FDA?
Euroimmun Anti-Dsdna-Ncx Elisa (Igg) (K083381) received a 510(k) decision of Substantially Equivalent on April 15, 2009, 152 days after the submission was received.
What is the product code of K083381?
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.