Varelisa Combined DNA Antibodies Eia
FDA 510(k) K944334 · Elias U.S.A., Inc.
510(k) numberK944334
Submission
- Device name
- Varelisa Combined DNA Antibodies Eia
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- September 6, 1994
- Decision date
- April 17, 1995
- 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 |
| K083381 | Euroimmun Anti-Dsdna-Ncx Elisa (Igg)LRM · Traditional | Euroimmun Us, Inc. | 04/15/2009SE |
| 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 |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
Questions and answers
When was Varelisa Combined DNA Antibodies Eia cleared by the FDA?
Varelisa Combined DNA Antibodies Eia (K944334) received a 510(k) decision of Substantially Equivalent on April 17, 1995, 223 days after the submission was received.
What is the product code of K944334?
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.