Autostattmii Anti-Dsdna
FDA 510(k) K952567 · Cogent Diagnotics , Ltd.
510(k) numberK952567
Submission
- Device name
- Autostattmii Anti-Dsdna
- Applicant
- Cogent Diagnotics , Ltd.
Edinburgh, GB - Received
- June 5, 1995
- Decision date
- March 4, 1997
- 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 |
|---|---|---|
| K003057 | Autostat II ENA-4 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K003054 | Autostat II ENA-6 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional | 09/28/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | 02/03/2000SE |
| K993085 | Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional | 02/01/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | 12/06/1999SE |
| K992449 | Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional | 11/24/1999SE |
| K993087 | Autostat II Anti-Gliadin Igg ElisaMST · Traditional | 11/12/1999SE |
| K993086 | Autostat II Anti-Gliadin Iga ElisaMST · Traditional | 11/12/1999SE |
Questions and answers
When was Autostattmii Anti-Dsdna cleared by the FDA?
Autostattmii Anti-Dsdna (K952567) received a 510(k) decision of Substantially Equivalent on March 4, 1997, 638 days after the submission was received.
What is the product code of K952567?
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.